Application 089560

Type: ANDA
Sponsor: SANDOZ INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	10%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A089560-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1988-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089560-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A089560-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089560-001	AT	1	`e64feba35796…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Asclemed USA, Inc.	c4c29e13-8303-4a9a-bb47-d7413eaf2f26	2022-10-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089560 application number: ANDA089560 ndc (product): 76420-076

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-525	Sulfacetamide Sodium	Sulfacetamide Sodium	Rebel Distributors Corp	ANDA	Current
52959-117	Sulfacetamide Sodium	Sulfacetamide Sodium	H.J. Harkins Company, Inc.	ANDA	Current
61314-701	Sulfacetamide Sodium	Sulfacetamide Sodium	Sandoz Inc.	ANDA	Current
61314-701	Sulfacetamide Sodium	Sulfacetamide Sodium	Sandoz Inc.	ANDA	Current
61314-701	Sulfacetamide Sodium	Sulfacetamide Sodium	Sandoz Inc.	ANDA	Current
61314-701	Sulfacetamide Sodium	Sulfacetamide Sodium	Sandoz Inc.	ANDA	Current
66267-941	Sulfacetamide Sodium	Sulfacetamide Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-941	Sulfacetamide Sodium	Sulfacetamide Sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68387-491	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	Keltman Pharmaceuticals Inc.	ANDA	Current
68788-7015	Sulfacetamide Sodium	Sulfacetamide Sodium	Preferred Pharmaceuticals	ANDA	Current
76420-076	Sulfacetamide Sodium	Sulfacetamide Sodium	Asclemed USA, Inc.	ANDA	Current
76420-076	Sulfacetamide Sodium	Sulfacetamide Sodium	Asclemed USA, Inc.	ANDA	Current