Application 091344

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A091344-001	MINOXIDIL	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2011-04-28

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091344-001	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL	2011-04-28	`f41ea6bd6efb…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
hers hair regrowth treatment	MINOXIDIL	Hims Inc	77b917ec-65ea-4c7c-941e-fc37f598294b	2022-04-18	Warnings	Exact identifier application applno (ANDA): 091344 application number: ANDA091344
equate hair regrowth treatment	MINOXIDIL	Wal-Mart Stores Inc	b5327990-654f-4c1f-8cd4-95470f12d767	2022-03-09	Warnings	Exact identifier application applno (ANDA): 091344 application number: ANDA091344 ndc (product): 49035-905
Good Sense Hair Regrowth Treatment	MINOXIDIL	L. Perrigo Company	6f939158-eb96-4479-9a4a-f5a11aa88295	2021-09-13	Warnings	Exact identifier application applno (ANDA): 091344 application number: ANDA091344 ndc (product): 0113-1129

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 113 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0113-0294	good sense hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-0294	good sense hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-1129	Good Sense Hair Regrowth Treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-1129	Good Sense Hair Regrowth Treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-1129	Good Sense Hair Regrowth Treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7129	basic care hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7129	basic care hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7294	basic care hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0113-7294	basic care hair regrowth treatment	Minoxidil	L. Perrigo Company	ANDA	Current
0363-0294	minoxidil	Minoxidil	Walgreen Company	ANDA	Current
0363-1129	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-1129	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-1129	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-2294	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-2294	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-2294	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
0363-2294	hair regrowth treatment	Minoxidil	Walgreen Company	ANDA	Current
11673-431	up and up hair regrowth treatment for women	Minoxidil	Target Corporation	ANDA	Current
11673-431	up and up hair regrowth treatment for women	Minoxidil	Target Corporation	ANDA	Current
11673-431	up and up hair regrowth treatment for women	Minoxidil	Target Corporation	ANDA	Current
11673-431	up and up hair regrowth treatment for women	Minoxidil	Target Corporation	ANDA	Current
11673-431	up and up hair regrowth treatment for women	Minoxidil	Target Corporation	ANDA	Current
11673-707	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-707	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-707	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11673-707	up and up hair regrowth treatment for men	Minoxidil	Target Corporation	ANDA	Current
11822-0129	Minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0129	Minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0129	Minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0129	Minoxidil	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0606	Daylogic For Men	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0606	Daylogic For Men	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0606	Daylogic For Men	Minoxidil	Rite Aid Corporation	ANDA	Current
11822-0606	Daylogic For Men	Minoxidil	Rite Aid Corporation	ANDA	Current
21130-163	signature care hair regrowth treatment for women	Minoxidil	Safeway	ANDA	Current
21130-163	signature care hair regrowth treatment for women	Minoxidil	Safeway	ANDA	Current
21130-163	signature care hair regrowth treatment for women	Minoxidil	Safeway	ANDA	Current
21130-750	Signature Care Hair Regrowth Treatment for men	Minoxidil	Safeway	ANDA	Current
21130-750	Signature Care Hair Regrowth Treatment for men	Minoxidil	Safeway	ANDA	Current
21130-750	Signature Care Hair Regrowth Treatment for men	Minoxidil	Safeway	ANDA	Current
30142-294	hair regrowth treatment for men	Minoxidil	Kroger Company	ANDA	Current
30142-294	hair regrowth treatment for men	Minoxidil	Kroger Company	ANDA	Current
30142-294	hair regrowth treatment for men	Minoxidil	Kroger Company	ANDA	Current
30142-294	hair regrowth treatment for men	Minoxidil	Kroger Company	ANDA	Current
30142-719	hair regrowth treatment	Minoxidil	Kroger Company	ANDA	Current
30142-719	hair regrowth treatment	Minoxidil	Kroger Company	ANDA	Current
30142-719	hair regrowth treatment	Minoxidil	Kroger Company	ANDA	Current
30142-719	hair regrowth treatment	Minoxidil	Kroger Company	ANDA	Current
37808-404	minoxidil	Minoxidil	H E B	ANDA	Current
37808-404	minoxidil	Minoxidil	H E B	ANDA	Current
41163-294	equaline hair regrowth treatment for men	Minoxidil	Supervalu Inc	ANDA	Current
41250-294	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-294	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-294	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-749	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-749	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-749	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
41250-749	hair regrowth treatment	Minoxidil	Meijer Distribution Inc	ANDA	Current
49035-294	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-294	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-905	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-905	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-905	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49035-905	equate hair regrowth treatment	Minoxidil	Wal-Mart Stores Inc	ANDA	Current
49738-084	smart sense hair regrowth	Minoxidil	Kmart Corporation	ANDA	Current
49738-300	Image Essentials Hair Regrowth Treatment	Minoxidil	Kmart Corporation	ANDA	Current
56062-294	minoxidil foam	Minoxidil	Publix Super Markets Inc	ANDA	Current
56062-294	minoxidil foam	Minoxidil	Publix Super Markets Inc	ANDA	Current
56062-294	minoxidil foam	Minoxidil	Publix Super Markets Inc	ANDA	Current
56062-294	minoxidil foam	Minoxidil	Publix Super Markets Inc	ANDA	Current
59779-294	hair regrowth treatment for men	Minoxidil	CVS Pharmacy	ANDA	Current
59779-294	hair regrowth treatment for men	Minoxidil	CVS Pharmacy	ANDA	Current
59779-294	hair regrowth treatment for men	Minoxidil	CVS Pharmacy	ANDA	Current
59779-294	hair regrowth treatment for men	Minoxidil	CVS Pharmacy	ANDA	Current
59779-294	hair regrowth treatment for men	Minoxidil	CVS Pharmacy	ANDA	Current
63940-294	harmon face values minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63940-385	Core Values Minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63940-385	Core Values Minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63940-385	Core Values Minoxidil	Minoxidil	Harmon Stores Inc.	ANDA	Current
63981-294	kirkland signature Minoxidil	Minoxidil	Costco Wholesale Company	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9333	ORIG	2011-05-03