Application 018182

Type: NDA
Sponsor: BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MYCELEX-7	CLOTRIMAZOLE	TABLET;VAGINAL	100MG	No	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
N018182-002	MYCELEX-7	CLOTRIMAZOLE	100MG	TABLET / VAGINAL			1991-12-26

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018182-002	MYCELEX-7	100MG	TABLET / VAGINAL	1991-12-26	`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 9 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terrasil Jock Itch Treatment Maximum Strength	CLOTRIMAZOLE	Aidance Skincare & Topical Solutions, LLC	c62fbf23-5d19-44ab-9c1a-e9b803192ed0	2023-11-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
terrasil The Fungal Solution Kit	CLOTRIMAZOLE	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	9a5eb581-62a2-41fe-a174-e852fc47e235	2023-11-08	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	800a9dab-d287-427e-af6d-26996e0def41	2023-11-01	Warnings	Name fallback generic name: CLOTRIMAZOLE
JOCK-EZE	CLOTRIMAZOLE	Bentlin Products LLC	d3ff5bfb-2e0f-4daa-84b3-4a3016ca9280	2023-10-30	Warnings	Name fallback generic name: CLOTRIMAZOLE
TheraPlus Plus	CLOTRIMAZOLE	Zhejiang Jingwei Pharmaceutical Co., Ltd.	de75179d-1889-4823-9f39-4bebdf185d76	2023-10-27	Warnings	Name fallback generic name: CLOTRIMAZOLE
Thera plus Antifungal Clotrimazole	CLOTRIMAZOLE	FOURSTAR GROUP USA, INC.	1265be99-8922-4b76-bd63-19bfb42c3896	2023-10-26	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	H2-Pharma, LLC	388f7e35-efbe-496b-a8d6-518caa22328d	2023-01-11	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Padagis US LLC	3f57ef51-8202-4d0b-95a8-d2df468b8d9a	2022-05-31	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Micomitin Antifungal	CLOTRIMAZOLE	PureTek Corporation	dd05f5f9-2412-1295-e053-2995a90acb96	2022-02-14	Warnings	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Proficient Rx LP	c62264a9-cea3-4461-9399-35d8931d38d5	2022-02-01	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE
Clotrimazole	CLOTRIMAZOLE	Hikma Pharmacuticals USA USA Inc.	0bc4b876-ddee-4f03-b44f-544348739a26	2021-07-30	Warnings, Adverse reactions	Name fallback generic name: CLOTRIMAZOLE

Reported adverse events (FAERS/openFDA)#

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