STRENZA PLUS

Manufacturer: Brisk Pharmaceuticals
Effective date: 2025-02-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:25:49

Label at a glance#

ProductSTRENZA PLUS

Active ingredientMOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE, PREDNISOLONE ACETATE, BROMFENAC SODIUM

Label structure3 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Rx Only

NDC 73614-732-03

For Use in Eyes Only

STRENZA Plus ™

Each Pack Contains:

Moxifloxacin Ophthalmic Solution, USP 0.5% - One 3 ml Bottle

Bromfenac Ophthalmic Solution 0.09% - One 1.7 ml Bottle

Prednisolone Acetate Ophthalmic Suspension, USP 1% - One 5 ml Bottle

Brisk Pharmaceuticals

DESCRIPTION SECTION

Packaged by:

Unit Dose Solutions Inc.,

Morrisville, NC 27560

Distributed by:

Brisk pharmaceuticals,

Richardson, TX 75081

Keep out of reach of children.

TAMPER EVIDENT: Do not use the individual eye drops inside the pack if the seal on its bottle is broken or missing.

Lot: See the lot number on each individual bottle inside the pack.

Exp: See the expiration date on each individual bottle inside the pack.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
578018	bromfenac 0.09 % Ophthalmic Solution	PSN	1
403818	moxifloxacin HCl 0.5 % Ophthalmic Solution	PSN	1
1376336	prednisoLONE acetate 1 % Ophthalmic Suspension	PSN	1
578018	bromfenac 0.9 MG/ML Ophthalmic Solution	SCD	1
403818	moxifloxacin 5 MG/ML Ophthalmic Solution	SCD	1
1376336	prednisolone acetate 10 MG/ML Ophthalmic Suspension	SCD	1
578018	bromfenac 0.09 % Ophthalmic Solution	SY	1
578018	bromfenac 0.9 MG/ML (bromfenac sodium 1.035 MG/ML) Ophthalmic Solution	SY	1
403818	moxifloxacin (as moxifloxacin HCl) 0.5 % Ophthalmic Solution	SY	1
1376336	prednisolone acetate 1 % Ophthalmic Suspension	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BROMFENAC Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108
MOXIFLOXACIN Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230421
PREDNISOLONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b3fecff3-fb51-4f66-b443-a130905bb500	Product name	1	20250804
e42b5738-f3b2-36cb-547c-d658794618bc	Product name	2	20250804
84b851da-be59-d750-14d1-e4d93cc3b4da	Product name	9	20250630
3a7a0034-a88d-88c3-f43e-ea34c6a216de	Product name	2	20250311
9dbc4744-f7be-4393-b71a-e1bfd8b97659	Product name	2	20250218
4ce8f27b-067c-45ad-b8f6-4b29ec66e497	Product name	2	20250115
b81a1117-443d-49e4-a709-58c3c32468af	Product name	5	20241010
2194a6ab-15bb-de49-cced-f09e642b1b64	Product name	8	20240313
9e44d9f9-cb87-3b0f-4c71-c8438d0dc2e5	Product name	2	20240102
a0e37fa3-7f16-4fbf-bdb7-ae82cb1a553a	Product name	1	20170309
af7d3306-1338-423f-839e-419aad9e8a86	Product name	1	20170309
ee6f8cae-1597-1a7e-3fb9-6aaeba954efe	Product name	3	20150902
d7840f4c-f22a-4403-b5da-53ac6ac8fd90	Product name	1	20150728
ccc7bb05-654a-45d2-a0d6-09ab96ba531b	Product name	2	20150611
8442aba0-7521-47cb-8a4e-c9896f35e8ae	Product name	3	20150317
18d57d04-4a34-a130-5dd5-b7fc47f3b567	Product name	1	20140508
379bc253-901a-e6e1-92b7-0fc574249e07	Product name	1	20140508
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508
73adedd8-aba8-27d9-78d9-2e3c4a3cf954	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
9f10552a-9a7b-8e6c-3223-dc44310af6cf	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73614-732-03	STRENZA PLUS	1 in 1 CARTON	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72266-142	STRENZA PLUS (MOXIFLOXACIN 0.5%, BROMFENAC 0.09%, PREDNISOLONE ACETATE 1%) KIT [BRISK PHARMACEUTICALS]	1	Current NDC, Legacy NDC	20250215_2df9064c-0527-4c21-e063-6294a90a56d8.zip
73614-732	STRENZA PLUS (MOXIFLOXACIN 0.5%, BROMFENAC 0.09%, PREDNISOLONE ACETATE 1%) KIT [BRISK PHARMACEUTICALS]	1	Current NDC, 1 package rows	20250215_2df9064c-0527-4c21-e063-6294a90a56d8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-422-01	ML - Milliliter	68180-422	e6bd441f-79e7-4e7a-9f6c-87d36199ac00	1	2017-08-11
61314-637-05	ML - Milliliter	61314-637	687ac068-dec0-4b7c-b191-c23c1e8fcb11	1	2012-07-24
61314-637-10	ML - Milliliter	61314-637	f2f42340-ae54-4b6a-b488-cbc294ba98a2	1	2012-07-24
61314-637-15	ML - Milliliter	61314-637	1b82c78e-4257-4c55-a503-631aebe636f3	1	2012-07-24
72266-142-01	ML - Milliliter	72266-142	30abb61d-0d53-4a88-9a43-0545891e8819	1	2020-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

STRENZA PLUS
Moxifloxacin 0.5%, Bromfenac 0.09%, Prednisolone Acetate 1%
Moxifloxacin
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE
BORIC ACID
WATER
HYDROCHLORIC ACID
SODIUM HYDROXIDE
SODIUM CHLORIDE
Prednisolone Acetate
BENZALKONIUM CHLORIDE
POLYSORBATE 80
PREDNISOLONE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
HYPROMELLOSE, UNSPECIFIED
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
GLYCERIN
Bromfenac
POVIDONE K30
SODIUM SULFITE
SODIUM BORATE
BROMFENAC SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73614-732	73614-732-03
68180-422
61314-637
72266-142	72266-142-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE	B8956S8609	ACTIM
BORIC ACID	R57ZHV85D4	IACT
WATER	059QF0KO0R	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
PREDNISOLONE ACETATE	8B2807733D	ACTIB
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
GLYCERIN	PDC6A3C0OX	IACT
WATER	059QF0KO0R	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM SULFITE	VTK01UQK3G	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
BORIC ACID	R57ZHV85D4	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM BORATE	91MBZ8H3QO	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
BROMFENAC SODIUM	8ECV571Y37	ACTIM

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 3 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202867-001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1		2014-09-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202867-001	AT1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS / OPHTHALMIC	AT1	2014-09-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202867-001	AT1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202867-001	AT1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202867-001	AT1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202867-001	AT1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202867-001	AT1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202867-001	AT1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202867-001	AT1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202867-001	AT1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202867-001	AT1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202867-001	AT1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202867-001	AT1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202867-001	AT1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202867-001	AT1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202867-001	AT1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202867-001	AT1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202867-001	AT1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202867-001	AT1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202867-001	AT1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202867-001	AT1	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202867-001	AT1	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202867-001	AT1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202867-001	AT1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202867-001	AT1	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202867-001	AT1	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202867-001	AT1	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202867-001	AT1	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202867-001	AT1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202867-001	AT1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202867-001	AT1	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202867-001	AT1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202867-001	AT1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202867-001	AT1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202867-001	AT1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202867-001	AT1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202867-001	AT1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202867-001	AT1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202867-001	AT1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202867-001	AT1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202867-001	AT1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202867-001	AT1	1	`f41ea6bd6efb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211029-001	BROMFENAC SODIUM	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2		2020-03-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A211029-001	AT2

Observed Orange Book product history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211029-001	BROMFENAC SODIUM	EQ 0.09% ACID	SOLUTION/DROPS / OPHTHALMIC	AT2	2020-03-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211029-001	AT2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211029-001	AT2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211029-001	AT2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211029-001	AT2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211029-001	AT2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211029-001	AT2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211029-001	AT2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211029-001	AT2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211029-001	AT2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211029-001	AT2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211029-001	AT2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211029-001	AT2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211029-001	AT2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211029-001	AT2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211029-001	AT2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211029-001	AT2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211029-001	AT2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211029-001	AT2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211029-001	AT2	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211029-001	AT2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211029-001	AT2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211029-001	AT2	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211029-001	AT2	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211029-001	AT2	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211029-001	AT2	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211029-001	AT2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211029-001	AT2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211029-001	AT2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211029-001	AT2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211029-001	AT2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211029-001	AT2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211029-001	AT2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211029-001	AT2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211029-001	AT2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211029-001	AT2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211029-001	AT2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211029-001	AT2	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211029-001	AT2	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211029-001	AT2	1	`a50c72e98297…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017469-001	OMNIPRED	PREDNISOLONE ACETATE	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N017469-001	AB

Observed Orange Book product history#

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017469-001	OMNIPRED	1%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N017469-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017469-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017469-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017469-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017469-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017469-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017469-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017469-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017469-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017469-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017469-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017469-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017469-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017469-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017469-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017469-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017469-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017469-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017469-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017469-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017469-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017469-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017469-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017469-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017469-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017469-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017469-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017469-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017469-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017469-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017469-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017469-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017469-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017469-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017469-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017469-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017469-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017469-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017469-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017469-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN	Lupin Pharmaceuticals, Inc.	ae77e219-8af9-4aa4-96d3-05c9726a1d3c	2025-10-13	Warnings, Adverse reactions	Exact identifier ndc (product): 68180-422
STRENZA PLUS	MOXIFLOXACIN 0.5%, BROMFENAC 0.09%, PREDNISOLONE ACETATE 1%	Brisk Pharmaceuticals	2df9064c-0527-4c21-e063-6294a90a56d8	2025-02-12		Exact identifier ndc (package): 72266-142-01 ndc (package): 73614-732-03 ndc (product): 73614-732 ndc11 (package): 72266014201 ndc11 (package): 73614073203 spl id: 2df9064c-0528-4c21-e063-6294a90a56d8 spl set id: 2df9064c-0527-4c21-e063-6294a90a56d8
BROMFENAC	BROMFENAC	Fosun Pharma USA Inc.	a8f1d85a-5585-4632-bdfa-a54a535b5c17	2025-01-22	Warnings, Adverse reactions	Exact identifier ndc (package): 72266-142-01 ndc (product): 72266-142 ndc11 (package): 72266014201
Prednisolone Acetate	PREDNISOLONE ACETATE	Sandoz Inc	05d205c7-8f51-46b9-a6c5-4199bc432b26	2024-12-30	Warnings, Adverse reactions	Exact identifier ndc (product): 61314-637

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.