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 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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020289-002	GYNE-LOTRIMIN COMBINATION PACK	1%,100MG	CREAM, TABLET / TOPICAL, VAGINAL	RLD	1993-04-26	`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 2 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FifthPulse Clotrimazole Antifungal	CLOTRIMAZOLE	WeCare Products LLC	9f5ea297-5a25-42cc-bd47-4159108b0023	2026-04-27	Warnings	Name fallback generic name: CLOTRIMAZOLE
SimplyVital Antifungal Clotrimazole	CLOTRIMAZOLE	Alpha Plants Inc	44881106-3ab4-4103-9c48-1da435ab5b13	2026-04-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	70e1efac-1738-43db-b19c-bbe02810b6e7	2026-04-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	caba588a-13df-4035-ac41-6b4ec90cd88d	2026-04-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	80d67df3-843d-47bb-85a2-d2f26a824336	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
RoyceDerm Antifungal Bar	CLOTRIMAZOLE	RoyceDerm LLC	3abdc4a8-58dd-5bd0-e063-6294a90a1bca	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals, Inc.	624827d6-dbf8-4f3d-a8c0-c92474cad7de	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	fd010006-f646-46ed-841a-9f247b19e397	2026-03-31	Warnings	Name fallback generic name: CLOTRIMAZOLE
Antifungal	CLOTRIMAZOLE	Dynarex Corporation	4d4cc4b4-c0b4-9e25-e063-6294a90a70b8	2026-03-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1%	CLOTRIMAZOLE	TAGRID LLC	4581d0c9-1f85-42c8-87d7-5f38fbbc923a	2026-03-15	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTIC (clotrimazole) otic solution	CLOTRIMAZOLE	Carwin Pharmaceutical Associates, LLC	ef0658c3-9c6b-4705-89d8-cf0644c80fcb	2026-03-03	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	e0a2a907-9c3a-4c4e-e053-2995a90abb91	2026-03-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE	CLOTRIMAZOLE	AARNA USA INC	4bd825f4-f5e2-aab7-e063-6394a90ad6a4	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Megababe Fun Gal Stuff Antifungal	CLOTRIMAZOLE	Megababe LLC	c599d27b-fdb0-465f-9e43-13d32c520a92	2026-02-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	d6f5c6b5-5e56-462f-8c47-7986ce53669d	2026-02-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Kerova ANTIFUNGAL	CLOTRIMAZOLE	Guangzhou Bixiaoyu Trading Co., Ltd.	4a7b48cf-72c3-be63-e063-6394a90a1efe	2026-02-10	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE 1%	CLOTRIMAZOLE	PHARMACY CHOICE INC	43852cfb-6d28-e54f-e063-6394a90aa090	2026-02-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Glenmark Pharmaceuticals Inc., USA	f6898117-14f3-42d2-bc0e-d296add3ad70	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Jock Itch Clotrimazole Antifungal	CLOTRIMAZOLE	WalMart	a7677ad4-5239-40da-809a-501b91caedbf	2026-01-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	bac80746-5cc3-4910-a0af-d43b8242acc6	2026-01-29	Warnings	Name fallback generic name: CLOTRIMAZOLE

Application 020289

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#