Application 017717

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	GYNE-LOTRIMIN	CLOTRIMAZOLE	TABLET;VAGINAL	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
N017717-002	GYNE-LOTRIMIN	CLOTRIMAZOLE	100MG	TABLET / VAGINAL		RLD	1990-11-30

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	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017717-002	GYNE-LOTRIMIN	100MG	TABLET / VAGINAL	RLD	1990-11-30	`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 4 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimazole	CLOTRIMAZOLE	Trifluent Pharma LLC	a3bafc52-1404-4e0b-84c1-e28bffcb091e	2025-12-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	A-S Medication Solutions	9afb964c-9b88-4701-adcf-7070e25cb6c1	2025-11-19	Warnings	Name fallback generic name: CLOTRIMAZOLE
AU KAH CHUEN ANTIFUNGAL	CLOTRIMAZOLE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	3a262bcd-e6c0-4554-ab1c-9c861f90e190	2025-11-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Cura Hongo Antifungal	CLOTRIMAZOLE	Pharmadel LLC	df031309-2778-00cf-e053-2a95a90a5eea	2025-11-17	Warnings	Name fallback generic name: CLOTRIMAZOLE
PerfectHeal Antifungal	CLOTRIMAZOLE	Zhejiang Dingtai Pharmaceutical Co., Ltd	d9750991-8f10-4d6b-8841-bea022d5ad73	2025-11-10	Warnings	Name fallback generic name: CLOTRIMAZOLE
HUA TUO XIAN GAO ANTIFUNGAL	CLOTRIMAZOLE	MADISON ONE ACME INC	e11c4d87-8dc2-44b1-bf6b-12e7ef4f3d1d	2025-11-10	Warnings	Name fallback generic name: CLOTRIMAZOLE
Family Care Antifungal	CLOTRIMAZOLE	United Exchange Corp.	63255079-ecf1-1e77-e053-2a91aa0a7b6c	2025-10-30	Warnings	Name fallback generic name: CLOTRIMAZOLE
WinCo Foods Antifungal	CLOTRIMAZOLE	Winco Foods LLC	c2ca0787-267a-10f4-e053-2a95a90a3a33	2025-10-28	Warnings	Name fallback generic name: CLOTRIMAZOLE
Signature Care Athletes Foot	CLOTRIMAZOLE	Safeway	c1750c17-4afb-aecf-e053-2a95a90af35b	2025-10-22	Warnings	Name fallback generic name: CLOTRIMAZOLE
Fungicure Liquid Gel	CLOTRIMAZOLE	Kobayashi Healthcare International, Inc.	dfd03852-29bd-4e16-97f3-64dfde5f8ff8	2025-10-21	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Marlex Pharmaceuticals Inc	d6e95c99-e055-436a-8ee6-40d6e199eaca	2025-10-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
LEADER ATHLETES FOOT CLOTRIMAZOLE	CLOTRIMAZOLE	LEADER	dcea717b-b097-4a40-8e38-05212731a7ef	2025-09-29	Warnings	Name fallback generic name: CLOTRIMAZOLE
RUGBY ANTIFUNGAL CLOTRIMAZOLE	CLOTRIMAZOLE	Rugby Laboratories	0b32a369-ea1c-4cb8-8ea1-07bba8f16b72	2025-09-16	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	77883cfd-f13c-40cb-88b2-8f777e1cdce9	2025-09-10	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Strategic Sourcing Services LLC	de3b6b64-dfa5-4abd-ba43-4ab59b4c2284	2025-09-09	Warnings	Name fallback generic name: CLOTRIMAZOLE
ANTIFUNGAL	CLOTRIMAZOLE	Encube Ethicals, Inc.	afbc28f8-bb76-424d-9d73-136e6c283ead	2025-09-04	Warnings	Name fallback generic name: CLOTRIMAZOLE
femmesil Ultra Therapy	CLOTRIMAZOLE	Aidance Scientific, Inc.	3d36794a-07d0-860c-e063-6294a90a6e8f	2025-08-25	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	TRIFECTA PHARMACEUTICALS USA LLC	6b74d405-42d6-4c46-ba78-3007d1e8ffb8	2025-08-23	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	AvPAK	3ca3b475-7b69-442a-e063-6294a90a7b3f	2025-08-18	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Foster and Thrive (Mckesson /STRATEGIC SOURCING SERVICES LLC)	474f5446-f9e3-4422-a9da-c7e23aaa0941	2025-07-30	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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