Application 072641

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLOTRIMAZOLE	CLOTRIMAZOLE	CREAM;VAGINAL	1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A072641-001	CLOTRIMAZOLE	CLOTRIMAZOLE	1%	CREAM / VAGINAL			1995-12-04

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072641-001	CLOTRIMAZOLE	1%	CREAM / VAGINAL	1995-12-04	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals, Inc.	624827d6-dbf8-4f3d-a8c0-c92474cad7de	2026-03-31	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 68788-9665
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	bac80746-5cc3-4910-a0af-d43b8242acc6	2026-01-29	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 50090-0614
Clotrimazole	CLOTRIMAZOLE	STRATEGIC SOURCING SERVICES LLC	8c7cc657-28a1-4720-97ce-098207bfc470	2025-07-21	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	f7192955-8f8c-45dd-a215-8ac2c1f6444f	2025-06-12	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 51672-2003
Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	ab0e14b8-8c64-435c-e053-2a95a90acfba	2024-07-17	Warnings	Exact identifier application applno (ANDA): 072641 application number: ANDA072641 ndc (product): 68071-4026

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-0614	Clotrimazole	Clotrimazole	A-S Medication Solutions	ANDA	Current
50090-0614	Clotrimazole	Clotrimazole	A-S Medication Solutions	ANDA	Current
51672-2003	Clotrimazole	Clotrimazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53002-9080	Clotrimazole	Clotrimazole	RPK Pharmaceuticals, Inc.	ANDA	Current
68071-4026	Clotrimazole	Clotrimazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4026	Clotrimazole	Clotrimazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-9665	Clotrimazole	Clotrimazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9665	Clotrimazole	Clotrimazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9665	Clotrimazole	Clotrimazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9665	Clotrimazole	Clotrimazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9665	Clotrimazole	Clotrimazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2932	Clotrimazole	Clotrimazole	REMEDYREPACK INC.	ANDA	Current
70518-2932	Clotrimazole	Clotrimazole	REMEDYREPACK INC.	ANDA	Current
76413-305	Clotrimazole	Clotrimazole	Central Texas Community Health Centers	ANDA	Current