Application 040066

Type: ANDA
Sponsor: BAUSCH AND LOMB

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
A040066-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040066-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1994-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040066-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1994-12-28	`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	A040066-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040066-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040066-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040066-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040066-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040066-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040066-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040066-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040066-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040066-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040066-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040066-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040066-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040066-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040066-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040066-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040066-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040066-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040066-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040066-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040066-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040066-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040066-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040066-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040066-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040066-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040066-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040066-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040066-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040066-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040066-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040066-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040066-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040066-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040066-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040066-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040066-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040066-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040066-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040066-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	A-S Medication Solutions	f212af23-be3d-4e82-9f6f-5ddce12a89da	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 50090-0246
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Preferred Pharmaceuticals, Inc	cf0cc763-49b5-435d-852b-e7617c8d3286	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 68788-9871
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	NuCare Pharmaceuticals,Inc.	9910ec80-e37c-6a83-e053-2995a90a8237	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 68071-5123
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Bausch & Lomb Incorporated	6c1b2658-e756-4f31-9bc8-f99a0baa4637	2023-08-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 24208-670
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Proficient Rx LP	2b4f125c-338e-479f-8feb-b82324230c65	2022-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 71205-689
Sulfacetamide Sodium	SULFACETAMIDE SODIUM	Asclemed USA, Inc.	129d5dd9-32a4-4398-862d-820cd4468448	2020-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040066 application number: ANDA040066 ndc (product): 76420-090

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
24208-670	Sulfacetamide Sodium	sulfacetamide sodium	Bausch & Lomb Incorporated	ANDA	Current
24208-670	Sulfacetamide Sodium	sulfacetamide sodium	Bausch & Lomb Incorporated	ANDA	Current
24208-670	Sulfacetamide Sodium	sulfacetamide sodium	Bausch & Lomb Incorporated	ANDA	Current
24208-670	Sulfacetamide Sodium	sulfacetamide sodium	Bausch & Lomb Incorporated	ANDA	Current
49999-144	Sulfacetamide Sodium	sulfacetamide sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-144	Sulfacetamide Sodium	sulfacetamide sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0246	Sulfacetamide Sodium	sulfacetamide sodium	A-S Medication Solutions	ANDA	Current
50090-0246	Sulfacetamide Sodium	sulfacetamide sodium	A-S Medication Solutions	ANDA	Current
50090-0246	Sulfacetamide Sodium	sulfacetamide sodium	A-S Medication Solutions	ANDA	Current
53002-9010	Sulfacetamide Sodium	sulfacetamide sodium	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-209	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	DIRECT RX	ANDA	Current
61919-209	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	DIRECT RX	ANDA	Current
68071-5123	Sulfacetamide Sodium	sulfacetamide sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5123	Sulfacetamide Sodium	sulfacetamide sodium	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9871	Sulfacetamide Sodium	sulfacetamide sodium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9871	Sulfacetamide Sodium	sulfacetamide sodium	Preferred Pharmaceuticals	ANDA	Current
68788-9871	Sulfacetamide Sodium	sulfacetamide sodium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9871	Sulfacetamide Sodium	sulfacetamide sodium	Preferred Pharmaceuticals, Inc	ANDA	Current
68788-9871	Sulfacetamide Sodium	sulfacetamide sodium	Preferred Pharmaceuticals, Inc	ANDA	Current
71205-689	Sulfacetamide Sodium	sulfacetamide sodium	Proficient Rx LP	ANDA	Current
76413-126	Sulfacetamide Sodium	sulfacetamide sodium	Central Texas Community Health Centers	ANDA	Current
76420-090	Sulfacetamide Sodium	sulfacetamide sodium	Asclemed USA, Inc.	ANDA	Current