Application 076773

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICONAZOLE 3	MICONAZOLE NITRATE	CREAM;VAGINAL	4%	No	No

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
A076773-001	MICONAZOLE 3	MICONAZOLE NITRATE	4%	CREAM / VAGINAL			2005-03-02

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076773-001	MICONAZOLE 3	4%	CREAM / VAGINAL	2005-03-02	`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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 3	MICONAZOLE NITRATE	TARGET Corporation	12a2e441-4fdf-4c5e-b033-ba05ef12fc2f	2025-07-18	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773 ndc (product): 11673-391
Lagicam antifungal	MICONAZOLE NITRATE	Genomma Lab USA, Inc.	85043273-7411-48f5-8ad4-3f00e03cafa3	2025-07-02	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773 ndc (product): 50066-070
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	eaca3e39-6ea0-4d7e-803c-db22024ad9f9	2025-07-01	Warnings	Exact identifier application applno (ANDA): 076773 application number: ANDA076773 ndc (product): 51672-2070

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11673-391	Miconazole 3	Miconazole Nitrate	TARGET Corporation	ANDA	Current
36800-070	TopCare	Miconazole Nitrate	Topco Associates LLC	ANDA	Current
36800-070	TopCare	Miconazole Nitrate	Topco Associates LLC	ANDA	Current
37012-070	Miconazole 3	Miconazole Nitrate	Shopko Stores Operating Co., LLC	ANDA	Current
41250-491	meijer	Miconazole Nitrate	Meijer Distribution Inc	ANDA	Current
50066-070	Lagicam	Miconazole Nitrate	Genomma Lab USA, Inc.	ANDA	Current
50066-070	Lagicam	Miconazole Nitrate	Genomma Lab USA, Inc.	ANDA	Current
51672-2070	Miconazole Nitrate	Miconazole Nitrate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2070	Miconazole Nitrate	Miconazole Nitrate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2070	Miconazole Nitrate	Miconazole Nitrate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
55315-737	Freds	Miconazole Nitrate	FRED'S, INC.	ANDA	Current
63868-197	Quality Choice	Miconazole Nitrate	Chain Drug Marketing Association	ANDA	Current
68016-070	Premier Value	Miconazole Nitrate	Pharmacy Value Alliance LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31164	ORIG	2005-03-03