Application 020289

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	GYNE-LOTRIMIN COMBINATION PACK	CLOTRIMAZOLE	CREAM, TABLET;TOPICAL, VAGINAL	1%,100MG	Yes	No

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

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
N020289-002	GYNE-LOTRIMIN COMBINATION PACK	CLOTRIMAZOLE	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL		RLD	1993-04-26

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`f41ea6bd6efb…`

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 8 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clotrimazole 1%	CLOTRIMAZOLE	Chain Drug Marketing Association Inc.	24ff5ad7-2ff9-b254-e063-6394a90a27a7	2024-10-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
CAREALL Clotrimazole	CLOTRIMAZOLE	New World Imports, Inc	ebc565bb-e56c-43ba-a5cb-d2fad2aafc4a	2024-10-07	Warnings	Name fallback generic name: CLOTRIMAZOLE
Micotrin AC	CLOTRIMAZOLE	PureTek Corporation	cbe4dd18-c9ef-a4e4-e053-2995a90a5289	2024-10-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Mycozyl AC	CLOTRIMAZOLE	PureTek Corporation	b676d257-3cfd-7f24-e053-2995a90a546e	2024-10-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole 1%	CLOTRIMAZOLE	Dabur India Limited	22916978-303f-e62a-e063-6394a90a2100	2024-09-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Major Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	562dfc9f-1897-330a-e054-00144ff8d46c	2024-08-14	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals, Inc.	54241254-1d9a-346a-e054-00144ff8d46c	2024-07-17	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	ab0e14b8-8c64-435c-e053-2a95a90acfba	2024-07-17	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	b63a3fe5-5684-41bc-ad6c-69c54e5b942d	2024-06-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	NuCare Pharmaceuticals,Inc.	627375fb-2f20-16bc-e053-2a91aa0a1542	2024-06-06	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Cardinal Health 110 dba LEADER	199df107-3384-6e03-e063-6294a90afc38	2024-05-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Femmesil	CLOTRIMAZOLE	Aidance Skincare & Topical Solutions, LLC	efddad82-9dc7-4cd9-b33c-7e85f30d992e	2024-05-24	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	QUALITY CHOICE (Chain Drug Marketing Association)	3c676ff0-44a8-40cd-8f85-d39dda3d9637	2024-05-23	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole Antifungal	CLOTRIMAZOLE	Trifecta Pharmaceuticals USA, LLC.	11bf50db-552e-0a39-e063-6394a90af60d	2024-02-19	Warnings	Name fallback generic name: CLOTRIMAZOLE
clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	eeb241a3-93ee-4b74-8cbb-65713d15e7e0	2024-01-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	ba1dc4a4-073f-4f30-bb9c-9ed043700431	2024-01-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Proficient Rx LP	7c64553b-589c-4e65-a6f0-b2847bbbe8a6	2024-01-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
AKIN ANTI-FUNGAL	CLOTRIMAZOLE	Southern Sales & Service, Inc.	7836127f-d472-4aac-9443-10f56d735d1f	2023-11-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
SIMPLY VITAL Antifungal Cream	CLOTRIMAZOLE	ALPHA PLANTS INC	d3842de3-0d13-4dc2-920b-90a4b822bbb8	2023-11-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Smooth Gator Fungus Eliminator	CLOTRIMAZOLE	Smooth Gator, LLC	262b04f5-1b5d-4c67-a557-01f8b1711302	2023-11-10	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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