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 6 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terrasil Tinea Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	d0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa	2025-07-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Tagrid Antifungal Treament Clotrimazole 1%	CLOTRIMAZOLE	TAGRID LLC	dff03e98-e2cf-4427-a87a-a7da1b04b3b6	2025-07-09	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	CVS Pharmacy	8731f4ca-84a0-4325-895b-35bf8e2ff0e1	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
CAREONE Clotrimazole	CLOTRIMAZOLE	American Sales Company	68915156-8927-4ace-9497-5e510d1edcca	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole Athletes Foot	CLOTRIMAZOLE	Wal-Mart Stores, Inc.	1440cf4d-e075-4137-a8ee-f41bd449c998	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Good Neighbor Pharmacy Clotrimazole	CLOTRIMAZOLE	AmerisourceBergen	adf75d72-26a7-4f4e-bba5-34a6fbe2a4cc	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Kroger ATHLETES FOOT	CLOTRIMAZOLE	Kroger Company	9e623f18-3e00-4952-b347-337d83fe3acb	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Kroger Jock Itch	CLOTRIMAZOLE	Kroger Company	cc536b67-8b0b-4939-b0fb-9a9e4188c4e5	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Rite Aid antifungal ringworm	CLOTRIMAZOLE	Rite Aid Corporation	1ad7cd82-d01b-403e-a2c1-2302db2a78df	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Walgreens Clotrimazole 3	CLOTRIMAZOLE	Walgreen Company	7fafdebd-b117-4a6b-a499-a4d3ac086ab9	2025-07-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole 1% Athletes Foot	CLOTRIMAZOLE	STRATEGIC SOURCING SERVICES LLC	9aba1345-ef47-4951-8448-a43d6696b616	2025-07-07	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	3e2041a0-8bef-4be4-b2b1-556446c4a778	2025-07-03	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	a3a5cbf5-cabb-48d8-8877-74a97f7c0f57	2025-07-03	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	325a40b0-3e17-47c6-8988-d5396ca5d53f	2025-07-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
meijer Athletes Foot	CLOTRIMAZOLE	Meijer Distribution Inc	fdb15cd8-6726-4150-9b9d-6ef3ee01a5d2	2025-07-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
Rexall Jock Itch	CLOTRIMAZOLE	Dollar General	11427a79-f262-4702-9b2e-ec1955a9b2da	2025-07-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
Rexall Athletes Foot	CLOTRIMAZOLE	Dollar General	664579a1-a5b0-4a4c-bff6-4347f3e1d3bb	2025-07-02	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Granules Pharmaceuticals Inc.	1280353c-9f96-557e-e063-6294a90a10f9	2025-06-30	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Sun Pharmaceutical Industries, Inc.	f7192955-8f8c-45dd-a215-8ac2c1f6444f	2025-06-12	Warnings	Name fallback generic name: CLOTRIMAZOLE
Terrasil Anti-Fungal Treatment MAX	CLOTRIMAZOLE	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	db356cc8-f473-4eb2-b8d8-72606fca9dc0	2025-05-23	Warnings	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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