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 10 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive miconazole	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	09c4f6c9-ba51-47f4-95b4-d236fa45778b	2023-10-25	Warnings	Name fallback generic name: MICONAZOLE NITRATE
careone miconazole 1	MICONAZOLE NITRATE	American Sales Company	f51af8e2-fb06-4842-8021-b7efd515022e	2023-10-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Kroger Company	9fc3df65-c441-44ab-aaac-f63b565ca2f5	2023-09-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Equaline Miconazole 7	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	7ebd51d9-8578-48c8-804a-e80fbe514fa1	2023-08-02	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	4bf1a555-a24f-4807-ac13-db19c55cf280	2023-01-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	H2-Pharma, LLC	67dc7d38-a663-48d5-9abf-b3bd8dc0eddf	2023-01-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
exchange select miconazole 1	MICONAZOLE NITRATE	Army & Air Force Exchange Service	672d935f-0807-44d1-8faa-94d416907095	2022-11-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Signature Care Miconazole 1	MICONAZOLE NITRATE	Safeway	5129e042-421e-41e3-a0be-90f12d12b40b	2022-11-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 1	MICONAZOLE NITRATE	H E B	40cc911b-2c35-4382-a979-fb1a165049db	2022-11-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Good Neighbor Pharmacy Miconazole 1	MICONAZOLE NITRATE	Amerisource Bergen	12c400dc-4fbf-4a10-9a4d-5156d65b509a	2022-11-09	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	QUALITY CHOICE (Chain Drug Marketing Association)	68667d2e-d4d0-46e7-9d84-0f23fdac1cf7	2022-09-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Basic Care Miconazole 7	MICONAZOLE NITRATE	Amazon.com Services LLC	4a828083-f5a9-46c3-a07a-3d151f155025	2021-08-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
basic care miconazole 3	MICONAZOLE NITRATE	Amazon.com Services LLC	e1457c13-6d35-41b2-b1e8-7e82b647a0c7	2021-07-26	Warnings	Name fallback generic name: MICONAZOLE NITRATE
HERS Miconazole 3	MICONAZOLE NITRATE	Hims Inc	1b2a36fb-48dd-451e-a804-c864be4e5326	2021-03-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Topco Miconazole 3	MICONAZOLE NITRATE	Topco Associates LLC	aef7be88-3cd7-484b-96a3-e9bbeca55e2a	2021-02-10	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole	MICONAZOLE NITRATE	H E B	83305fd6-2154-4b1b-aaec-3e2e56708fdb	2021-02-09	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Topcare Miconazole 7	MICONAZOLE NITRATE	Topco Associates LLC	351905b1-f78c-4838-a036-23b2bfc775f2	2021-02-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
signature care miconazole 7	MICONAZOLE NITRATE	Safeway	2e04ac2d-cfbc-4261-a8f9-03715f819c1c	2021-02-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Signature Care Miconazole 3	MICONAZOLE NITRATE	Safeway	191e448b-0410-4102-82ae-a3387b27b227	2021-02-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Good Neighbor Pharmacy Miconazole 7	MICONAZOLE NITRATE	Amerisource Bergen	5a3441e8-f4fc-404f-8e9e-6d2aee2b8cec	2021-01-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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