Application 207609

Type: ANDA
Sponsor: HI TECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	SUSPENSION/DROPS;OPHTHALMIC	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207609-001	LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB		2019-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207609-001	AB

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 2 of 2 · 44 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
2022-10-28 04:53 UTC	2022-10	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207609-001	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	2019-04-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207609-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207609-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207609-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207609-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207609-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207609-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207609-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207609-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207609-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207609-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207609-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207609-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207609-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207609-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207609-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207609-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207609-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207609-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207609-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207609-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207609-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207609-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207609-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207609-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207609-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207609-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207609-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207609-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207609-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207609-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207609-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207609-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207609-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207609-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207609-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207609-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207609-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207609-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207609-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207609-001	AB	1	`3a93d1ddd44b…`

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
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Sentiss Pharmaceuticals LLC	4faa8cbe-2004-e8b5-e063-6394a90a3550	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207609 application number: ANDA207609
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	ARMAS PHARMACEUTICALS INC.	08a091a8-748f-acc4-e063-6394a90af4bc	2023-10-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207609 application number: ANDA207609

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-265	Loteprednol Etabonate	Loteprednol Etabonate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-265	Loteprednol Etabonate	Loteprednol Etabonate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-265	Loteprednol Etabonate	Loteprednol Etabonate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-265	Loteprednol Etabonate	Loteprednol Etabonate	Akorn	ANDA	Current
50383-265	Loteprednol Etabonate	Loteprednol Etabonate	Hi-Tech Pharmacal Co., Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58816	ORIG	2019-05-21