Application 021143

Type: NDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIVAGIZOLE 3	CLOTRIMAZOLE	CREAM;VAGINAL	2%	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
N021143-001	TRIVAGIZOLE 3	CLOTRIMAZOLE	2%	CREAM / VAGINAL			2000-04-12

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	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021143-001	TRIVAGIZOLE 3	2%	CREAM / VAGINAL	2000-04-12	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole	CLOTRIMAZOLE	Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)	474f5446-f9e3-4422-a9da-c7e23aaa0941	2025-07-30	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143
Good Neighbor Pharmacy Clotrimazole 3	CLOTRIMAZOLE	AmerisourceBergen	2a7c3bd5-0ff4-46d2-b5d1-ef8637d0f530	2025-07-28	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143 ndc (product): 24385-110
sunmark Clotrimazole 3	CLOTRIMAZOLE	Strategic Sourcing Services LLC	0bc5d91a-c4ea-4fe9-80e0-6f76aa073e7b	2025-07-21	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143 ndc (product): 49348-379
CVS Pharmacy Clotrimazole 3	CLOTRIMAZOLE	CVS Pharmacy	37000f9c-a1a4-4e5a-80c8-c9a1b2490a71	2025-07-17	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143 ndc (product): 69842-062
Walgreens Clotrimazole 3	CLOTRIMAZOLE	Walgreen Company	7fafdebd-b117-4a6b-a499-a4d3ac086ab9	2025-07-08	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143 ndc (product): 0363-2062
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	325a40b0-3e17-47c6-8988-d5396ca5d53f	2025-07-02	Warnings	Exact identifier application applno (NDA): 021143 application number: NDA021143 ndc (product): 51672-2062

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-2062	Walgreens	Clotrimazole	Walgreen Company	NDA	Current
24385-110	Good Neighbor Pharmacy	Clotrimazole	AmerisourceBergen	NDA	Current
24385-110	Good Neighbor Pharmacy	Clotrimazole	AmerisourceBergen	NDA	Current
36800-062	TopCare	Clotrimazole	Topco Associates LLC	NDA	Current
41250-062	meijer	Clotrimazole	Meijer Distribution Inc	NDA	Current
49348-379	sunmark	Clotrimazole	McKesson	NDA	Current
49348-379	sunmark	Clotrimazole	Strategic Sourcing Services LLC	NDA	Current
51672-2062	Clotrimazole	Clotrimazole	Taro Pharmaceuticals U.S.A., Inc.	NDA	Current
59779-062	CVS Pharmacy	Clotrimazole	CVS Pharmacy	NDA	Current
69772-200	CANESTEN	CLOTRIMAZOL	GENESIS IMPORTS & EXPORTS LLC	NDA	Current
69842-062	CVS Pharmacy	Clotrimazole	CVS Pharmacy	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45178	SUPPL	2016-08-25
45065	SUPPL	2016-08-25
41980	ORIG	2001-07-30
14487	ORIG	2000-04-12
4451	ORIG	2000-04-12