Application 020525

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GYNE-LOTRIMIN 3	CLOTRIMAZOLE	TABLET;VAGINAL	200MG	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
N020525-001	GYNE-LOTRIMIN 3	CLOTRIMAZOLE	200MG	TABLET / VAGINAL		RLD	1996-07-29

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	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020525-001	GYNE-LOTRIMIN 3	200MG	TABLET / VAGINAL	RLD	1996-07-29	`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 7 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
terrasil Folliculitis Cream Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	35d54756-00dd-bbe1-e063-6394a90a9e02	2025-05-23	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tagrid Antifungal Ringworm Treatment 1% CLOTRIMAZOLE	CLOTRIMAZOLE	TAGRID LLC	34af91bb-e04b-d252-e063-6294a90aaf96	2025-05-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Cardinal Health (Leader) 70000	4aaae616-179b-40f1-8a39-6a1ddd414070	2025-04-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
ANTIFUNGAL	CLOTRIMAZOLE	VIVE HEALTH LLC	33db98f5-f6d9-742a-e063-6394a90a2a03	2025-04-28	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	GERI-GENTLE CORPORATION	e673748f-d00b-4ce8-e053-2995a90a9220	2025-04-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE	CLOTRIMAZOLE	Rising Pharma Holdings, Inc.	980736aa-751a-4642-ab85-a309435fd02f	2025-03-27	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Forticept Antifungal Foot Gel	CLOTRIMAZOLE	Lidan, Inc.	1b5851fc-ae73-4e54-bb62-3ff928628b97	2025-03-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Dermatin Antifungal	CLOTRIMAZOLE	Melaleuca, Inc.	e993fa3b-1d85-46b7-bda5-ed875be74c4e	2025-03-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Forticept Antifungal Foot Cream	CLOTRIMAZOLE	Lidan, Inc.	17abeb4d-b211-4b8c-a9d2-4c7baba2450c	2025-03-07	Warnings	Name fallback generic name: CLOTRIMAZOLE
DG Health Athletes Foot	CLOTRIMAZOLE	Dolgencorp, Inc.	20370b32-21ad-4362-9b46-c6149c907231	2025-02-28	Warnings	Name fallback generic name: CLOTRIMAZOLE
Family Wellness Clotrimazole 1 Anti Fungal Cream	CLOTRIMAZOLE	Family Dollar Stores, Inc	0667dd81-5633-494e-857e-45fa276fe72c	2025-02-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Preferred Pharmaceuticals Inc.	0052992a-819c-4c55-bd88-201a09a3573a	2025-02-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
Dr Sheffield Athletes Foot	CLOTRIMAZOLE	Sheffield Pharmaceuticals LLC	b8b8e6b2-1022-4592-91ba-3cf94c7cf318	2025-02-19	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	116be3a8-9a57-4b4a-a873-98a4ce83bcf7	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
terrasil Fungal Treatment	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	278290f9-be14-81a8-e063-6294a90ad8cc	2024-12-26	Warnings	Name fallback generic name: CLOTRIMAZOLE
Rugby Clotrimazole Antifungal Cream	CLOTRIMAZOLE	Rugby Laboratories	a1365bc7-b376-adca-e053-2a95a90acf19	2024-12-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Terrasil JockItch Treatment Maximum Strength	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	8afe11c1-0a85-4255-8eba-e8cbde0759a0	2024-11-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
Terrasil Ringworm Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	fc2b740a-49c1-4a01-a94c-8cade52a2b82	2024-11-20	Warnings	Name fallback generic name: CLOTRIMAZOLE
CLOTRIMAZOLE	CLOTRIMAZOLE	ALLIED TRADE LINK LLC	266d7b94-2954-4831-e063-6394a90a3f33	2024-11-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	6b908538-d9ff-41d0-909c-01e1d1b21a39	2024-10-23	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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