Application 062452

Type: ANDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GENOPTIC	GENTAMICIN SULFATE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.3% BASE	No	Yes

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
A062452-001	GENOPTIC	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A062452-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	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
GENTAMICIN SULFATE	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	85424b40-5c2d-421d-e053-2991aa0a7771	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452 ndc (product): 68071-4827
gentamicin sulfate	GENTAMICIN SULFATE	DIRECT RX	51a411a0-2671-4c1c-bf25-e29b32efed0c	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062452 application number: ANDA062452 ndc (product): 61919-106

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-187	GENTAMICIN SULFATE	gentamicin sulfate	Rebel Distributors Corp	ANDA	Current
33261-604	GENTAMICIN SULFATE	gentamicin sulfate	Aidarex Pharmaceuticals LLC	ANDA	Current
35356-707	GENTAMICIN SULFATE	gentamicin sulfate	Lake Erie Medical & Surgical Suppy DBA Quality Care Products LLC	ANDA	Current
50090-2333	GENTAMICIN SULFATE	gentamicin sulfate	A-S Medication Solutions	ANDA	Current
53002-9292	GENTAMICIN SULFATE	gentamicin sulfate	RPK Pharmaceuticals, Inc.	ANDA	Current
60758-188	GENTAMICIN SULFATE	gentamicin sulfate	Pacific Pharma, Inc.	ANDA	Current
61919-106	gentamicin sulfate	gentamicin sulfate	DIRECT RX	ANDA	Current
61919-106	gentamicin sulfate	gentamicin sulfate	DIRECT RX	ANDA	Current
61919-106	gentamicin sulfate	gentamicin sulfate	DIRECT RX	ANDA	Current
63187-163	GENTAMICIN SULFATE	gentamicin sulfate	Proficient Rx LP	ANDA	Current
63187-163	GENTAMICIN SULFATE	gentamicin sulfate	Proficient Rx LP	ANDA	Current
63187-163	GENTAMICIN SULFATE	gentamicin sulfate	Proficient Rx LP	ANDA	Current
68071-4827	GENTAMICIN SULFATE	gentamicin sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4827	GENTAMICIN SULFATE	gentamicin sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9921	GENTAMICIN SULFATE	gentamicin sulfate	Preferred Pharmaceuticals, Inc.	ANDA	Current