Application 074366

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	CREAM;VAGINAL	2%	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
A074366-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1996-02-22

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	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074366-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1996-02-22	`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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	Safeway	b32aec61-32c0-4c7f-b843-348243332583	2025-11-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
VAGISTAT 3	MICONAZOLE NITRATE	Combe Incorporated	e15a28cd-9e64-4e9e-8df9-829d84f1816c	2025-11-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-fungal Powder Miconazole Nitrate	MICONAZOLE NITRATE	Meijer Distribution Inc	03fd069d-685d-b8ac-e063-6394a90a31f8	2025-10-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	H E B	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	2025-10-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Azolen	MICONAZOLE NITRATE	Stratus Pharmaceuticals, Inc.	9c2574f3-3be4-405a-9c87-943dc6ef8777	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazorb AF	MICONAZOLE NITRATE	AmerisourceBergen Drug Corporation	13a20d21-42d5-fe56-e063-6394a90aaf57	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Liquid Continuous	MICONAZOLE NITRATE	Family Dollar Services, Inc	17cc4601-f946-df8b-e063-6394a90a3897	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole nitrate	ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY	GEISS, DESTIN AND DUNN, INC.	c367c2e8-5423-bf01-e053-2a95a90ab8e9	2025-10-30	Warnings	Name fallback brand name: Miconazole nitrate
Miconazole Nitrate	JOCK ITCH SPRAY	Harris Teeter, LLC	636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb	2025-10-30	Warnings	Name fallback brand name: Miconazole Nitrate
HEB Athlete Foot Antifungal	MICONAZOLE NITRATE	HEB	2e204111-b5d3-0220-e063-6294a90a67bb	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	JOCK ITCH SPRAY	Kroger Co.	86bdf8a6-3a1f-457b-e053-2991aa0a5810	2025-10-30	Warnings	Name fallback brand name: Miconazole Nitrate
Anti-Fungal Powder	MICONAZOLE NITRATE	The Kroger Co.	209cd0ed-3029-9137-e063-6394a90aa93d	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Miconazole Liquid Continuous	MICONAZOLE NITRATE	Meijer Distribution Inc	030f2a31-334b-a6d8-e063-6394a90a98fc	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Jock Itch	MICONAZOLE NITRATE	Meijer Distribution Inc.	030f1316-ab3c-ce37-e063-6394a90a0f88	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Athletes Foot	MICONAZOLE NITRATE	Meijer Distribution Inc	030f2a31-3357-a6d8-e063-6394a90a98fc	2025-10-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	ANTIFUNGAL MICONAZOLE POWDER SPRAY	Winco Foods, LLC	cc24f4ca-a403-0dc4-e053-2a95a90a5dad	2025-10-29	Warnings	Name fallback brand name: Miconazole Nitrate
Remedy Antifungal	MICONAZOLE NITRATE	Medline Industries, LP	021b4a31-d7f6-4921-b4b1-cbe832eecd93	2025-10-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE	Discount Drug Mart, Inc	37790bf8-6114-84b9-e063-6394a90ad58d	2025-10-29	Warnings	Name fallback brand name: Miconazole Nitrate
Anti-fungal Powder Miconazole Nitrate	MICONAZOLE NITRATE	Premier Brands of America Inc.	052d8d02-2381-1e3a-e063-6394a90aa07e	2025-10-29	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Monistat 3 Combination Pack	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	e1b8ad40-5adb-482a-b532-3f8e30d90128	2025-10-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0252	Miconazole Nitrate	Miconazole Nitrate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0252	Miconazole Nitrate	Miconazole Nitrate	G&W Laboratories, Inc.	ANDA	Current
50090-0462	Miconazole Nitrate	Miconazole Nitrate	A-S Medication Solutions	ANDA	Current
70518-0811	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current
70518-0811	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current
76413-318	Miconazole Nitrate	Miconazole Nitrate	Central Texas Community Health Centers	ANDA	Current