Application 076585

Type: ANDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICONAZOLE 7 COMBINATION PACK	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,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
A076585-001	MICONAZOLE 7 COMBINATION PACK	MICONAZOLE NITRATE	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL			2004-03-26

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076585-001	MICONAZOLE 7 COMBINATION PACK	2%,100MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	2004-03-26	`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 9 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VAGISTEN-V 7 DAY	MICONAZOLE NITRATE	OPMX LLC	a5bfa501-5ae1-4434-bc31-995d0665b99e	2024-09-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	ASTONEA LABS PRIVATE LIMITED	e66191a6-0c3c-7319-e053-2a95a90aae84	2024-06-25	Warnings	Name fallback generic name: MICONAZOLE NITRATE
THERA Antifungal Body	MICONAZOLE NITRATE	McKesson Medical-Surgical Inc.	31096041-28c9-4b16-bbd1-dbadefd37505	2024-06-14	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Body	MICONAZOLE NITRATE	McKesson	4fb9aece-0baa-475e-e054-00144ff8d46c	2024-06-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	QUALITY CHOICE (Chain Drug Marketing Association)	84bef1d3-e4f8-4769-8f94-5ae91ddc9537	2024-06-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-Fungal	MICONAZOLE NITRATE	Universal Distribution Center LLC	8f316b0d-d308-4ae6-82c4-39bb0d1d474e	2024-05-21	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Cardinal Health (Leader) 70000	5081411c-02d0-4f7d-8496-d6adccbe00ae	2024-03-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Dermachange Jock	MICONAZOLE NITRATE	Private label Beauty and Wellness	12eef049-76c9-1450-e063-6394a90a00ea	2024-03-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7a0ef38a-9584-4e67-ba86-c31f86da1ed0	2023-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7d284f6f-a970-49fe-b45a-d5c6c2688bc2	2023-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 7	MICONAZOLE NITRATE	H E B	9741b8c0-716a-4c54-9793-387866faf766	2023-11-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	4abee369-e8c5-4971-9545-8c015ff6eaad	2023-11-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MacerRx Web	MICONAZOLE NITRATE	Clinical Therapeutic Solutions	c9327f41-10f1-41f3-855b-838c701d6767	2023-11-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
foster and thrive miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	b06590b5-1dcf-47b7-8e81-5887b1c3893a	2023-11-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Evercare Antifungal Treatment Super Absorbent Powder	MICONAZOLE NITRATE	PANEFFORT, LLC	f91910f3-b461-43a4-9120-fda69483fffa	2023-10-26	Warnings	Name fallback generic name: MICONAZOLE NITRATE
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

Reported adverse events (FAERS/openFDA)#

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