Application 062341

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	SUSPENSION/DROPS;OPHTHALMIC	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A062341-001	MAXITROL	DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT		1984-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062341-001	AT

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062341-001	MAXITROL	0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	SUSPENSION/DROPS / OPHTHALMIC	AT	1984-05-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062341-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062341-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062341-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062341-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062341-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062341-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062341-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062341-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062341-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062341-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062341-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062341-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062341-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062341-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062341-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062341-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062341-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062341-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062341-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062341-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062341-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062341-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062341-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062341-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062341-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062341-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062341-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062341-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062341-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062341-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062341-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062341-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062341-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062341-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062341-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062341-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062341-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062341-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062341-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062341-001	AT	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	Sandoz Inc.	cf1a6da8-ba79-4bff-a13b-6effb67f6c1c	2025-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062341 application number: ANDA062341 ndc (product): 61314-630
Neomycin and Polymyxin B Sulfates and Dexamethasone	NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	54da7bef-c3b0-4353-e054-00144ff8d46c	2024-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062341 application number: ANDA062341 ndc (product): 68071-3359

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33261-551	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Aidarex Pharmaceuticals LLC	ANDA	Current
49999-141	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
49999-141	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
49999-141	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-1957	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	A-S Medication Solutions	ANDA	Current
50090-3068	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	A-S Medication Solutions	ANDA	Current
50090-3068	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	A-S Medication Solutions	ANDA	Current
53002-9511	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	RPK Pharmaceuticals, Inc.	ANDA	Current
61314-630	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Sandoz Inc.	ANDA	Current
61314-630	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Sandoz Inc.	ANDA	Current
61314-630	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Sandoz Inc.	ANDA	Current
61314-630	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Sandoz Inc.	ANDA	Current
68071-3359	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-3359	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7686	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9120	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2198	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	REMEDYREPACK INC.	ANDA	Current
70518-2198	Neomycin and Polymyxin B Sulfates and Dexamethasone	neomycin sulfate, polymyxin b sulfate and dexamethasone	REMEDYREPACK INC.	ANDA	Current