Application 074414

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	SUPPOSITORY;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
A074414-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL			1997-04-30

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	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074414-001	MICONAZOLE NITRATE	100MG	SUPPOSITORY / VAGINAL	1997-04-30	`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 2 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	Rite Aid Corporation	78b6ac87-3de0-44e9-9e28-b4c7ab028fd5	2026-07-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
equate miconazole 1	MICONAZOLE NITRATE	Wal-Mart Stores Inc	5c5b0486-9ec2-4e14-a35c-80da8e62c59e	2026-07-06	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 Nitrate	ATHLETES FOOT LIQUID	Walgreens Company	94f4f656-e8a3-4439-b53c-12be59dc8eac	2026-06-20	Warnings	Name fallback brand name: Miconazole Nitrate
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	327095bd-a7c9-291d-e063-6394a90afafa	2026-06-09	Warnings	Name fallback brand name: Miconazole Nitrate
Miconazole Nitrate	ATHLETES FOOT POWDER SPRAY TALC FREE	Chain Drug Marketing Association	edc2da26-ae46-4175-86ed-83e1a65f6d14	2026-06-09	Warnings	Name fallback brand 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
Miconazole 7	MICONAZOLE NITRATE	Meijer Distribution Inc	b8417956-4c53-444e-823a-a87748eb0a08	2026-05-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Pharmlitalia Jock Itch Miconazole Nitrate	MICONAZOLE NITRATE	Rida LLC	bb9e3e35-abd8-4f7b-a8e3-90218940fd6b	2026-04-28	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0197	Miconazole Nitrate	Miconazole Nitrate	Cosette Pharmaceuticals, Inc.	ANDA	Current
0713-0197	Miconazole Nitrate	Miconazole Nitrate	G&W Laboratories, Inc.	ANDA	Current
42254-295	Miconazole Nitrate	Miconazole Nitrate	Rebel Distributors Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42845	ORIG	2005-07-22