Application 018520

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	MONISTAT 7	MICONAZOLE NITRATE	SUPPOSITORY;VAGINAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N018520-002	MONISTAT 7	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL		RLD, RS	1991-02-15

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018520-002	MONISTAT 7	100MG	SUPPOSITORY / VAGINAL	RLD, RS	1991-02-15	`cb3db0bc1861…`

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 1 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3 Walgreen Company	MICONAZOLE NITRATE	WALGREEN COMPANY	32b373be-9c8e-49b0-a796-8d87f6a20cef	2026-07-21	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Ringworm Treatment Cream	MICONAZOLE NITRATE	Yunqi Cosmetics (Shenzhen) Co., Ltd	56a2ceea-c4c0-c30c-e063-6394a90a0e6a	2026-07-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Gemachlich Zu Hause Vaginal Antifungal Gel	MICONAZOLE NITRATE	Guangzhou Xinhongda Trading Service Co., Ltd.	563cfb57-f10c-96a6-e063-6294a90a2b93	2026-07-10	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	85a52081-d9cc-44f0-a8d3-851a45c4eb10	2026-07-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	99c66cbd-7063-4b4c-b827-4f2fcb6ed67f	2026-07-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	78b6ac87-3de0-44e9-9e28-b4c7ab028fd5	2026-07-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Terpenicol Antifungal Cream	MICONAZOLE NITRATE	Blaine Labs Inc.	9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa	2026-07-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Terpenicol Antifungal Solution	MICONAZOLE NITRATE	Blaine Labs Inc.	f17ef2cd-5923-4df5-a7fe-aeef167e1e86	2026-07-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Walgreens	0d991104-df96-49b8-b146-67f47b5fcd20	2026-06-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Cream	MICONAZOLE NITRATE	Aldermed Inc.	4a7fc48a-c103-dc84-e063-6394a90ab80f	2026-06-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Powder	MICONAZOLE NITRATE	Aldermed Inc.	60954089-5220-4f4c-8595-b5ee4562562c	2026-06-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
good sense miconazole 7	MICONAZOLE NITRATE	Preferred Pharmaceuticals Inc.	9e0af5f8-249e-434a-a9c6-eb2f4045d9f6	2026-06-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Jock Itch Powder	MICONAZOLE NITRATE	Walgreens Company	06d2f36c-8615-af08-e063-6394a90aa424	2026-06-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 7	MICONAZOLE NITRATE	HyVee Inc	53b9bcb3-ff43-4849-9f72-84febe255328	2026-06-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Athletes Foot	MICONAZOLE NITRATE	Premier Brands of America Inc	52d0909a-f404-0af4-e063-6394a90a3d0c	2026-06-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Terramed Just Think Comfort Jock Itch Antifungal Treatment	MICONAZOLE NITRATE	Rida LLC	2acb9027-8f20-4b77-9b45-17fe11622c7c	2026-05-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE 7	MICONAZOLE NITRATE	Safeway	2f19d76f-1348-483e-8720-612d30928bb5	2026-05-26	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-Fungal Powder	MICONAZOLE NITRATE	CVS Pharmacy	1651bdd7-ab15-7a2d-e063-6294a90a8b91	2026-05-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	c915a495-8eac-4a1a-83a4-c874682433c8	2026-05-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 1 Walgreens	MICONAZOLE NITRATE	WALGREEN COMPANY	9679f4a5-c27b-46ea-9983-c2a111d3d2c3	2026-05-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Application 018520

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#