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 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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075598-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2001-06-13	`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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 11673-317
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 ndc (product): 25280-006
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 ndc (product): 11822-1260
minoxidil	MINOXIDIL	Publix Super Markets Inc	57699890-6fef-4bd8-b690-161458131cd7	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 56062-322
hair regrowth treatment	MINOXIDIL	Walgreen Company	fb2a8bfe-7eae-4a78-a610-58c9e80adf72	2025-07-17	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 0363-0032
Hair Regrowth Treatment	MINOXIDIL	CVS Pharmacy	7041e548-e3ff-4623-8c35-783c64d5f04c	2025-05-22	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 69842-598
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 ndc (product): 68196-032
minoxidil	MINOXIDIL	THIRTY MADISON INC	9a8528df-3cd3-4c85-b7e9-0a0e761d6cbd	2025-05-20	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598
hair regrowth treatment	MINOXIDIL	Kroger Company	3cacbf09-243e-4f5c-9878-4e191c0dd92a	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 30142-632
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
hair regrowth treatment	MINOXIDIL	Meijer, Inc.	847ec102-ee04-4168-9b85-c66bb01a1161	2025-02-05	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 41250-428
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 ndc (product): 63981-032
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 ndc (product): 63981-798
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	a3bfdd6f-2b41-406e-8a20-c1e5de0c186b	2024-07-18	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 0113-1032
minoxidil	MINOXIDIL	H E B	a05bc954-d369-4eb6-8a7d-d68955af874f	2024-05-13	Warnings	Exact identifier application applno (ANDA): 075598 application number: ANDA075598 ndc (product): 37808-833
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
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 (product): 49035-746

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 96 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0798	Good Sense Hair Regrowth Treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-0798	Good Sense Hair Regrowth Treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-1032	Good Sense Hair Regrowth Treatment	minoxidil	L. Perrigo Company	ANDA	Current
0113-1032	Good Sense Hair Regrowth Treatment	minoxidil	L. Perrigo Company	ANDA	Current
0113-7032	basic care hair regrowth treatment	minoxidil	L. Perrigo Company	ANDA	Current
0113-7798	Basic Care Hair Regrowth	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7798	Basic Care Hair Regrowth	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7798	Basic Care Hair Regrowth	Minoxidil	L. Perrigo Company	ANDA	Current
0363-0032	hair regrowth treatment	minoxidil	Walgreen Company	ANDA	Current
0363-0032	hair regrowth treatment	minoxidil	Walgreen Company	ANDA	Current
0363-0032	hair regrowth treatment	minoxidil	Walgreen Company	ANDA	Current
0363-0798	minoxidil	Minoxidil	Walgreen Company	ANDA	Current
0363-2798	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-2798	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
11509-0798	just for men minoxidil	Minoxidil	Combe Incorporated	ANDA	Current
11509-0798	just for men minoxidil	Minoxidil	Combe Incorporated	ANDA	Current
11673-317	up and up hair regrowth treatment for men	minoxidil	Target Corporation	ANDA	Current
11673-632	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-632	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-632	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-798	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11822-0798	minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0798	minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0798	minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0798	minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-1033	minoxidil	minoxidil	Rite Aid Corporation	ANDA	Current
11822-1260	hair regrowth treatment	minoxidil	Rite Aid Corporation	ANDA	Current
21130-273	signature care hair regrowth treatment	Minoxidil	Safeway	ANDA	Current
21130-273	signature care hair regrowth treatment	Minoxidil	Safeway	ANDA	Current
21130-819	signature care hair regrowth treatment	minoxidil	Safeway	ANDA	Current
25280-006	Loesch Hair Regrowth Formula	Minoxidil	Loesch Laboratory Consultants, Inc.	ANDA	Current
25280-006	Loesch Hair Regrowth Formula	minoxidil	Loesch Laboratory Consultant, INC.	ANDA	Current
30142-632	hair regrowth treatment	minoxidil	Kroger Company	ANDA	Current
30142-798	Hair Regrowth Treatment	Minoxidil	Kroger Company	ANDA	Current
30142-798	Hair Regrowth Treatment	Minoxidil	Kroger Company	ANDA	Current
37808-798	minoxidil	Minoxidil	H E B	ANDA	Current
37808-798	minoxidil	Minoxidil	H E B	ANDA	Current
37808-833	minoxidil	minoxidil	H E B	ANDA	Current
41163-798	Equaline hair regrowth treatment	Minoxidil	Supervalu Inc	ANDA	Current
41163-798	Equaline hair regrowth treatment	Minoxidil	Supervalu Inc	ANDA	Current
41250-428	hair regrowth treatment	minoxidil	Meijer, Inc.	ANDA	Current
41250-798	Hair Regrowth Treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-798	Hair Regrowth Treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
49035-746	equate hair regrowth treatment	minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-798	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-798	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-798	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49738-385	Smart Sense Hair Regrowth	Minoxidil	Kmart Corporation	ANDA	Current
56062-322	minoxidil	minoxidil	Publix Super Markets Inc	ANDA	Current
56062-798	Minoxidil	Minoxidil	Publix Super Markets Inc	ANDA	Current
56062-798	Minoxidil	Minoxidil	Publix Super Markets Inc	ANDA	Current
56062-798	Minoxidil	Minoxidil	Publix Super Markets Inc	ANDA	Current
59779-798	Hair regrowth	Minoxidil	CVS Pharmacy	ANDA	Current
59779-798	Hair regrowth	Minoxidil	CVS Pharmacy	ANDA	Current
59779-798	Hair regrowth	Minoxidil	CVS Pharmacy	ANDA	Current
63940-032	core values minoxidil	minoxidil	Harmon Stores Inc.	ANDA	Current
63940-582	Core Values Minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63940-582	Core Values Minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63940-798	harmon face values minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63981-032	kirkland signature minoxidil	minoxidil	Costco Wholesale Company	ANDA	Current
63981-380	Kirkland Signature Minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current
63981-380	Kirkland Signature Minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current
63981-798	kirkland signature minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current
63981-798	kirkland signature minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current
63981-798	kirkland signature minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current
68196-032	members mark hair regrowth treatment	minoxidil	Sam's West Inc	ANDA	Current
68196-401	Members Mark Minoxidil	Minoxidil	Sam's West Inc	ANDA	Current
68196-823	members mark hair regrowth treatment	Minoxidil	Sam's West Inc	ANDA	Current
68196-823	members mark hair regrowth treatment	Minoxidil	Sam's West Inc	ANDA	Current
68391-302	berkley and jensen minoxidil	minoxidil	BJWC	ANDA	Current
69282-002	Nioxin Hair Regrowth Treatment Extra Strength for Men	Minoxidil	The Wella Corporation	ANDA	Current
69282-002	Nioxin Hair Regrowth Treatment Extra Strength for Men	Minoxidil	The Wella Corporation	ANDA	Current
69842-598	Hair Regrowth Treatment	minoxidil	CVS Pharmacy	ANDA	Current
69842-598	Hair Regrowth Treatment	minoxidil	CVS Pharmacy	ANDA	Current
71177-002	Nutrastim	Minoxidil	Pulsaderm Llc	ANDA	Current
71177-005	Nutrastim	Minoxidil	Pulsaderm Llc	ANDA	Current
71517-001	minoxidil solution	minoxidil solution	Nutrastim Hair LLC	ANDA	Current
71517-001	minoxidil solution	minoxidil solution	Nutrastim Hair LLC	ANDA	Current
71713-093	keeps minoxidil topical	Minoxidil	THIRTY MADISON INC	ANDA	Current
71713-093	keeps minoxidil topical	Minoxidil	THIRTY MADISON INC	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