Application 005963

Type: NDA
Sponsor: SCHERING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM SULAMYD	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	SODIUM SULAMYD	SULFACETAMIDE SODIUM	OINTMENT;OPHTHALMIC	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	SODIUM SULAMYD	SULFACETAMIDE SODIUM	SOLUTION/DROPS;OPHTHALMIC	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N005963-001	SODIUM SULAMYD	SULFACETAMIDE SODIUM	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982
N005963-002	SODIUM SULAMYD	SULFACETAMIDE SODIUM	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982
N005963-003	SODIUM SULAMYD	SULFACETAMIDE SODIUM	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N005963-001	SODIUM SULAMYD	10%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005963-002	SODIUM SULAMYD	10%	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N005963-003	SODIUM SULAMYD	30%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N005963-001	SODIUM SULAMYD	10%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005963-002	SODIUM SULAMYD	10%	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N005963-003	SODIUM SULAMYD	30%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N005963-003	SODIUM SULAMYD	30% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N005963-001	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N005963-002	SODIUM SULAMYD	10% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / OPHTHALMIC	RLD, Approved before 1982	`c0c555d07b60…`

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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Preferred Pharmaceuticals, Inc	cf0cc763-49b5-435d-852b-e7617c8d3286	2026-09-02	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	A-S Medication Solutions	f212af23-be3d-4e82-9f6f-5ddce12a89da	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
OVACE	SULFACETAMIDE SODIUM	Mission Pharmacal Company	a77aed6c-355f-44ed-ae95-78b4d1549c2b	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Sodium Sulfacetamide, Sulfur	SULFACETAMIDE SODIUM	BioComp Pharma, Inc.	ed616ece-09b5-41d5-ae58-8e016da2c6b3	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	BioComp Pharma, Inc.	f79c8287-a832-4f39-ad4d-3a12d64618ab	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
OVACE Plus	SULFACETAMIDE SODIUM	Mission Pharmacal Company	eca5fc5d-35d0-4803-990d-1f38f860c52a	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
OVACE Plus	SULFACETAMIDE SODIUM	Mission Pharmacal Company	6a034465-e600-49cb-91bd-7b9ceee6ffc6	2025-12-03	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
Ovace Plus	SULFACETAMIDE SODIUM	Mission Pharmacal Company	073a44cd-f679-48bd-b90d-cf06f32ff07d	2025-08-13	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
OvacePlus Plus	SULFACETAMIDE SODIUM	Mission Pharmacal Company	06876575-edf2-4844-8f20-3eb6e74ccc8e	2025-08-12	Warnings, Adverse reactions	Name fallback generic name: SULFACETAMIDE SODIUM
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

Reported adverse events (FAERS/openFDA)#

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