Application 020288

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MONISTAT 7 COMBINATION PACK	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,100MG	Yes	Yes

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
N020288-002	MONISTAT 7 COMBINATION PACK	MICONAZOLE NITRATE	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL		RLD, RS	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 · 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	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020288-002	MONISTAT 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	RLD, RS	1993-04-26	`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 8 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	14d2a661-a490-41ca-b84f-f2be3bc271b4	2025-03-24	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Athletes Foot	MICONAZOLE NITRATE	Rida LLC	85e98ef8-75c3-4be1-b59f-40b5312e2137	2025-03-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	bf131f33-3ab2-4f43-add5-920e78ac36a7	2025-02-24	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Silka Athletes Foot	MICONAZOLE NITRATE	Genomma Lab USA	307104a2-2df6-43b0-bf3f-f4d93d3e40f1	2025-02-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	fd7dd2eb-03a7-ef1f-e053-6294a90a8557	2025-02-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	NuCare Pharmaceuticals,Inc.	0c055a0d-1031-e7d5-e063-6294a90a17e2	2025-02-03	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	Walgreen Company	0600418d-77ec-4f2d-a08e-1bf5ec634904	2025-01-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 1	MICONAZOLE NITRATE	Meijer Distribution Inc	c34d9917-ee79-4afb-9338-6f18e63b2b09	2025-01-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2%	MICONAZOLE NITRATE	Akron Pharma Inc.	8933f939-098a-4257-8d9c-4d5c3240e9a6	2025-01-10	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kit	MICONAZOLE NITRATE	Cosette Pharmaceuticals, Inc.	eed88487-a7ba-4853-8519-13f92ed5539f	2025-01-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Vite20	MICONAZOLE NITRATE	Blaine Labs Inc.	28a8d0dd-aab9-44ff-bab6-7ec4b5036a71	2024-12-24	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Rugby	f420de00-408f-9a2c-e053-2995a90adced	2024-12-17	Warnings	Name fallback generic name: MICONAZOLE NITRATE
up and up miconazole	MICONAZOLE NITRATE	Target Corporation	b626313a-b8aa-43fe-b8a9-475009ea5b53	2024-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Dr. Rainer s Vaginal Cream	MICONAZOLE NITRATE	Plexoris Health Care Products, Llc	1f0ee635-c70d-4194-a01d-370ca5c22fcd	2024-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 1 yeast infection relief	MICONAZOLE NITRATE	CVS Pharmacy	b0e5320b-73d5-4e96-8ce4-9a858e9d2ed3	2024-12-10	Warnings	Name fallback generic name: MICONAZOLE NITRATE
BOA VIDA Antifungal	MICONAZOLE NITRATE	Central Solutions Inc	69c5340d-9abd-43bf-a90b-9568d615f06f	2024-12-09	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE NITRATE	MICONAZOLE NITRATE	ALLIED TRADE LINK LLC	25520dba-0159-2a3f-e063-6294a90a4c33	2024-11-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MONISTAT 7 7-DAY DISPOSABLE APPLICATORS	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	c4b68aff-e95f-47ae-b190-6a671bef1877	2024-11-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	P & L Development, LLC	facc7b65-0376-445a-8a3d-5180f2f9d5ff	2024-11-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Basic Care Miconazole	MICONAZOLE NITRATE	Amazon.com Services LLC	962bef75-1583-4782-bfba-52a68876eedc	2024-11-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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