Application 083021

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	10%	No	No
002	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	15%	No	No
003	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	30%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A083021-001	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982
A083021-002	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982
A083021-003	SODIUM SULFACETAMIDE	SULFACETAMIDE SODIUM	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083021-002	SODIUM SULFACETAMIDE	15%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083021-003	SODIUM SULFACETAMIDE	30%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083021-001	SODIUM SULFACETAMIDE	10%	SOLUTION/DROPS / OPHTHALMIC	Approved before 1982	`301d65b070ca…`

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 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM SULFACETAMIDE	SODIUM SULFACETAMIDE	Akron Pharma Inc	ba08bf7c-5fdc-447a-b8de-3f319cee7e4e	2024-09-24	Warnings, Adverse reactions	Name fallback brand name: SODIUM SULFACETAMIDE
SODIUM SULFACETAMIDE	SODIUM SULFACETAMIDE	Akron Pharma Inc	732dc306-069f-4cbf-9398-8a057829b83e	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: SODIUM SULFACETAMIDE
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	Cintex Services, LLC	214ff8a6-179f-b907-e063-6394a90adcb1	2024-09-04	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	NuCare Pharmaceuticals,Inc.	9910ec80-e37c-6a83-e053-2995a90a8237	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	Cintex Services, LLC	0fa3302e-b2b4-6b9b-e063-6394a90abc2c	2024-01-23	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Bausch & Lomb Incorporated	6c1b2658-e756-4f31-9bc8-f99a0baa4637	2023-08-31	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Padagis Israel Pharmaceuticals Ltd	4fb4d39a-330e-4c84-abbc-3b33b36b206f	2023-04-01	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Asclemed USA, Inc.	c4c29e13-8303-4a9a-bb47-d7413eaf2f26	2022-10-12	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Proficient Rx LP	2b4f125c-338e-479f-8feb-b82324230c65	2022-08-01	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	KMM Pharmaceuticals, LLC	cdb5b3dc-9f75-85b7-e053-2a95a90a380c	2022-02-14	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
PLEXION NS	SULFACETAMIDE SODIUM	Eckson Labs, LLC	cdb4c921-e671-6f06-e053-2995a90abd1e	2022-02-10	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Asclemed USA, Inc.	129d5dd9-32a4-4398-862d-820cd4468448	2020-10-24	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Klaron	SULFACETAMIDE SODIUM	Bausch Health US, LLC	66ab38ea-5cea-47be-97f2-486517999fb0	2020-08-31	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sodium sulfacetamide	SODIUM SULFACETAMIDE	Oceanside Pharmaceuticals	6fa7399b-4ced-492d-b6f6-cf155764087a	2019-05-31	Warnings, Adverse reactions	Name fallback brand name: Sodium sulfacetamide

Reported adverse events (FAERS/openFDA)#

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