Application 062196

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

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

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
A062196-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	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
A062196-001	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 2 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
2022-09-29 23:25 UTC	2022-09	A062196-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062196-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A062196-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS, Approved before 1982	`a50c72e98297…`

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	A062196-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062196-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062196-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062196-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062196-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062196-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062196-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062196-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062196-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062196-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062196-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062196-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062196-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062196-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062196-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062196-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062196-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062196-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062196-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062196-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062196-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062196-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062196-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062196-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062196-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062196-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062196-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062196-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062196-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062196-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062196-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062196-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062196-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062196-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062196-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062196-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062196-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062196-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062196-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062196-001	AT	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
Gentamicin Sulfate	GENTAMICIN SULFATE	Proficient Rx LP	5193ed8d-44c9-46fe-924d-93aaea922cfd	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062196 application number: ANDA062196 ndc (product): 71205-333
Gentamicin Sulfate	GENTAMICIN SULFATE	NuCare Pharmaceuticals,Inc.	82595309-304e-a221-e053-2991aa0ac0a9	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062196 application number: ANDA062196 ndc (product): 68071-4775
Gentamicin Sulfate	GENTAMICIN SULFATE	Sandoz Inc	a213fb9c-08ea-4f30-a6c9-93c7a9ba5280	2024-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062196 application number: ANDA062196 ndc (product): 61314-633
Gentamicin Sulfate	GENTAMICIN SULFATE	Asclemed USA, Inc.	a54e5c95-609d-4d66-9573-5d1ac78fa58f	2022-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062196 application number: ANDA062196 ndc (product): 76420-137

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 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-1883	Gentamicin Sulfate	Gentamicin Sulfate	A-S Medication Solutions	ANDA	Current
53002-9291	Gentamicin Sulfate	Gentamicin Sulfate	RPK Pharmaceuticals, Inc.	ANDA	Current
61314-633	Gentamicin Sulfate	Gentamicin Sulfate	Sandoz Inc	ANDA	Current
61314-633	Gentamicin Sulfate	Gentamicin Sulfate	Sandoz Inc	ANDA	Current
61314-633	Gentamicin Sulfate	Gentamicin Sulfate	Sandoz Inc	ANDA	Current
61314-633	Gentamicin Sulfate	Gentamicin Sulfate	Sandoz Inc	ANDA	Current
68071-4775	Gentamicin Sulfate	Gentamicin Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4775	Gentamicin Sulfate	Gentamicin Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4775	Gentamicin Sulfate	Gentamicin Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4775	Gentamicin Sulfate	Gentamicin Sulfate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7336	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7336	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7336	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7336	Gentamicin Sulfate	Gentamicin Sulfate	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate	REMEDYREPACK INC.	ANDA	Current
70518-1323	Gentamicin Sulfate	Gentamicin Sulfate	REMEDYREPACK INC.	ANDA	Current
71205-333	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current
71205-333	Gentamicin Sulfate	Gentamicin Sulfate	Proficient Rx LP	ANDA	Current
76420-137	Gentamicin Sulfate	Gentamicin Sulfate	Asclemed USA, Inc.	ANDA	Current