Application 074444

Type: ANDA
Sponsor: TARO PHARMS

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 42.

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
A074444-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	2%	CREAM / VAGINAL			1997-01-13

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074444-001	MICONAZOLE NITRATE	2%	CREAM / VAGINAL	1997-01-13	`e64feba35796…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	6b34d0be-4bcd-4dff-b732-7fbd46765019	2026-08-25	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444 ndc (product): 51672-2035
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	a32fc37b-bcad-4f56-8dc6-cf36a6716196	2026-02-19	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444 ndc (product): 50090-4356
Miconazole 7	MICONAZOLE NITRATE	TARGET Corporation	edaca770-bc76-4ac2-bad2-cf8e7de0c682	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444 ndc (product): 11673-049
Miconazole 7	MICONAZOLE NITRATE	CVS Pharmacy	5e7e4cf8-24ec-486e-9389-546ffea004d0	2025-05-27	Warnings	Exact identifier application applno (ANDA): 074444 application number: ANDA074444 ndc (product): 69842-988

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-049	Miconazole 7	Miconazole Nitrate	TARGET Corporation	ANDA	Current
37012-035	Miconazole 7	Miconazole Nitrate	Shopko Stores Operating Co., LLC	ANDA	Current
50090-4356	Miconazole Nitrate	Miconazole Nitrate	A-S Medication Solutions	ANDA	Current
50090-4356	Miconazole Nitrate	Miconazole Nitrate	A-S Medication Solutions	ANDA	Current
50090-4356	Miconazole Nitrate	Miconazole Nitrate	A-S Medication Solutions	ANDA	Current
51672-2035	Miconazole Nitrate	Miconazole Nitrate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2035	Miconazole Nitrate	Miconazole Nitrate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55315-815	Miconazole Nitrate	Miconazole Nitrate	FRED'S, INC.	ANDA	Current
68788-8985	Miconazole Nitrate	Miconazole Nitrate	Preferred Pharmaceuticals Inc.	ANDA	Current
69842-988	Miconazole 7	Miconazole Nitrate	CVS Pharmacy	ANDA	Current
69842-988	Miconazole 7	Miconazole Nitrate	CVS Pharmacy	ANDA	Current
70518-2338	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current
70518-2338	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current
70518-2338	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current
70518-2338	Miconazole Nitrate	Miconazole Nitrate	REMEDYREPACK INC.	ANDA	Current