Application 075598

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	5%	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
A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION / TOPICAL			2001-06-13

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	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	a3bfdd6f-2b41-406e-8a20-c1e5de0c186b	2026-08-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
up and up hair regrowth treatment for men	MINOXIDIL	Target Corporation	545e3e21-6333-4d85-8754-b7a6201234b7	2026-04-09	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Loesch Hair Regrowth Formula Unscented Topical Solution Extra-Strength for Men	MINOXIDIL	Loesch Laboratory Consultant, INC.	d158d3af-6850-48c0-8355-9df0637684cc	2025-12-03	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Rite Aid Corporation	00c83180-0e13-4a07-9ce8-a9cae19a79a3	2025-10-08	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	Publix Super Markets Inc	57699890-6fef-4bd8-b690-161458131cd7	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Walgreen Company	fb2a8bfe-7eae-4a78-a610-58c9e80adf72	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
Hair Regrowth Treatment	MINOXIDIL	CVS Pharmacy	7041e548-e3ff-4623-8c35-783c64d5f04c	2025-05-22	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
members mark hair regrowth treatment	MINOXIDIL	Sam's West Inc	b3377092-b00d-4ab0-b62e-acd108dc330c	2025-05-22	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	THIRTY MADISON INC	9a8528df-3cd3-4c85-b7e9-0a0e761d6cbd	2025-05-20	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 71713-094
hair regrowth treatment	MINOXIDIL	Kroger Company	3cacbf09-243e-4f5c-9878-4e191c0dd92a	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hims hair regrowth treatment	MINOXIDIL	Hims Inc	c3caf0cd-9148-4696-9cb8-ec93cab3f9f5	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 71730-000
hair regrowth treatment	MINOXIDIL	Meijer, Inc.	847ec102-ee04-4168-9b85-c66bb01a1161	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	ec4b79fd-f68b-4f8d-a173-983835bc82eb	2025-02-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
equate hair regrowth treatment	MINOXIDIL	WALMART INC.	d57919c3-c6e1-4d84-bfa5-d4159d1c6c48	2024-09-23	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Safeway	cc99123b-b1a3-4818-9a06-e64478871c16	2024-08-20	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	010ca7df-1e79-44ea-9171-b9d239f141e1	2024-07-18	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
minoxidil	MINOXIDIL	H E B	a05bc954-d369-4eb6-8a7d-d68955af874f	2024-05-13	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	9d5e7acb-3892-4163-9f44-26e430959aa7	2024-04-23	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 72288-798
Leader Minoxidil	MINOXIDIL	Cardinal Health 110, LLC. dba Leader	fbb17735-6c1f-44d6-865b-feec83a66b69	2024-03-04	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	98f780ad-dc07-4d37-a05d-fc7b45b0c474	2021-09-29	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71713-093	keeps minoxidil topical	Minoxidil	THIRTY MADISON INC	ANDA	Current
71713-094	minoxidil	minoxidil	THIRTY MADISON INC	ANDA	Current
71730-000	hims hair regrowth treatment	minoxidil	Hims Inc	ANDA	Current
71730-798	hims minoxidil	Minoxidil	Hims Inc	ANDA	Current
71730-798	hims minoxidil	Minoxidil	Hims Inc	ANDA	Current
71730-798	hims minoxidil	Minoxidil	Hims, Inc.	ANDA	Current
71730-798	hims minoxidil	Minoxidil	Hims, Inc.	ANDA	Current
71730-798	hims minoxidil	Minoxidil	Hims, Inc.	ANDA	Current
72288-798	basic care hair regrowth treatment	minoxidil	Amazon.com Services LLC	ANDA	Current
82157-001	Nioxin Hair Regrowth Treatment	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-001	Nioxin Hair Regrowth Treatment	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-001	Nioxin Hair Regrowth Treatment	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-100	Nioxin Hair Regrowth Kit	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-100	Nioxin Hair Regrowth Kit	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-100	Nioxin Hair Regrowth Kit	Minoxidil	Wella Operations US LLC	ANDA	Current
82157-100	Nioxin Hair Regrowth Kit	Minoxidil	Wella Operations US LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22487	ORIG	2015-07-22
8733	ORIG	2004-06-09
8734	ORIG	2001-06-13