Application 091366

Type: ANDA
Sponsor: PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICONAZOLE NITRATE	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
A091366-001	MICONAZOLE NITRATE	MICONAZOLE NITRATE	4%	CREAM / VAGINAL			2010-01-15

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	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091366-001	MICONAZOLE NITRATE	4%	CREAM / VAGINAL	2010-01-15	`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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GOOD SENSE MICONAZOLE 3	MICONAZOLE NITRATE	L. Perrigo Company	906dcf48-63d8-44cf-a699-d1f30c84a029	2025-11-29	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366
miconazole 3	MICONAZOLE NITRATE	Walgreen Company	0600418d-77ec-4f2d-a08e-1bf5ec634904	2025-01-27	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366 ndc (product): 0363-2070
basic care miconazole 3	MICONAZOLE NITRATE	Amazon.com Services LLC	e1457c13-6d35-41b2-b1e8-7e82b647a0c7	2021-07-26	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366 ndc (product): 72288-070
HERS Miconazole 3	MICONAZOLE NITRATE	Hims Inc	1b2a36fb-48dd-451e-a804-c864be4e5326	2021-03-04	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366 ndc (product): 71730-070
Topco Miconazole 3	MICONAZOLE NITRATE	Topco Associates LLC	aef7be88-3cd7-484b-96a3-e9bbeca55e2a	2021-02-10	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366 ndc (product): 36800-782
Miconazole	MICONAZOLE NITRATE	H E B	83305fd6-2154-4b1b-aaec-3e2e56708fdb	2021-02-09	Warnings	Exact identifier application applno (ANDA): 091366 application number: ANDA091366 ndc (product): 37808-928

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-7070	basic care miconazole 3	miconazole nitrate	L. Perrigo Company	ANDA	Current
0113-7070	basic care miconazole 3	miconazole nitrate	L. Perrigo Company	ANDA	Current
0363-2070	miconazole 3	miconazole nitrate	Walgreen Company	ANDA	Current
36800-782	Topco Miconazole 3	miconazole nitrate	Topco Associates LLC	ANDA	Current
36800-782	Topco Miconazole 3	miconazole nitrate	Topco Associates LLC	ANDA	Current
37808-928	Miconazole	miconazole nitrate	H E B	ANDA	Current
37808-928	Miconazole	miconazole nitrate	H E B	ANDA	Current
71730-070	HERS Miconazole 3	miconazole nitrate	Hims, Inc.	ANDA	Current
71730-070	HERS Miconazole 3	miconazole nitrate	Hims Inc	ANDA	Current
71730-070	HERS Miconazole 3	miconazole nitrate	Hims Inc	ANDA	Current
72288-070	basic care miconazole 3	miconazole nitrate	Amazon.com Services LLC	ANDA	Current