Application 074588

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	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
A074588-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1996-04-05

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	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074588-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-04-05	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	Walgreens	b55198cb-40d8-432b-bdd5-2ecefa35d320	2025-05-21	Warnings	Exact identifier application applno (ANDA): 074588 application number: ANDA074588 ndc (product): 0363-9970

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9970	Minoxidil	Minoxidil	Walgreens	ANDA	Current
0363-9972	Minoxidil	Minoxidil	Walgreens	ANDA	Current
0472-0066	Hair Regrowth Treatment	minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-0066	Minoxidil	Minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-0066	Minoxidil	Minoxidil	Actavis Pharma, Inc.	ANDA	Current
0472-0066	Minoxidil	Minoxidil	Actavis Pharma, Inc.	ANDA	Current
59779-066	Minoxidil for Women	Minoxidil	CVS Pharmacy	ANDA	Current
60900-555	Re-Gro	minoxidil	Empress Hair Products, Ltd.	ANDA	Current
68016-006	Minoxidil	Minoxidil	Chain Drug Consortium, LLC	ANDA	Current
68016-006	Hair Regrowth Treatment for Women	Minoxidil	Chain Drug Consortium, LLC	ANDA	Current
68016-006	Minoxidil	Minoxidil	Chain Drug Consortium, LLC	ANDA	Current
68016-006	Minoxidil	Minoxidil	Chain Drug Consortium, LLC	ANDA	Current
71205-490	Minoxidil	Minoxidil	Proficient Rx LP	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71700-112	GETTIK Hair Regrowth Treatment	MINOXIDIL 5%	GETTIK International LLC	ANDA	Current
71713-095	Keeps	Minoxidil 5%	Thirty Madison Inc	ANDA	Current