Application 075619

Type: ANDA
Sponsor: AVACOR PRODS

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 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
A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	MINOXIDIL	5%	SOLUTION / TOPICAL			2000-11-17

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	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075619-001	MINOXIDIL EXTRA STRENGTH (FOR MEN)	5%	SOLUTION / TOPICAL	2000-11-17	`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 11 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL	P & L Development, LLC	73dc7e7f-92c2-4ab2-a260-ceb198e591cf	2024-11-05	Warnings	Name fallback generic name: MINOXIDIL
Elevate Hair Regrowth Treatment 5	MINOXIDIL	VAPOR PRO SHOPPE, LLC	0d5e4258-a58d-4378-9be8-631114588cdb	2024-10-31	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	b18e42ee-e5fa-441f-a6b6-1eb17836d668	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment	MINOXIDIL	Good Manager Holdings Inc	16b36a38-72c3-4a19-a28c-757ae02e097a	2024-10-28	Warnings	Name fallback generic name: MINOXIDIL
equate hair regrowth treatment	MINOXIDIL	WALMART INC.	d57919c3-c6e1-4d84-bfa5-d4159d1c6c48	2024-09-23	Warnings	Name fallback generic name: MINOXIDIL
Womens Rogaine Unscented	MINOXIDIL	Kenvue Brands LLC	8bf0000c-95f3-4a4d-830b-f5ac1539823d	2024-09-06	Warnings	Name fallback generic name: MINOXIDIL
Mens Rogaine Extra Strength Unscented	MINOXIDIL	Kenvue Brands LLC	ccaecec5-5348-4b24-9190-5464c50f6d80	2024-09-06	Warnings	Name fallback generic name: MINOXIDIL
KERANIQUE Hair Regrowth Treatment For Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	8d580c01-a13d-81f8-e053-2a95a90a7426	2024-08-22	Warnings	Name fallback generic name: MINOXIDIL
Keranique 2% Hair Regrowth Treatment for Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	c781447a-10f1-70e3-e053-2995a90a40f8	2024-08-22	Warnings	Name fallback generic name: MINOXIDIL
hair regrowth treatment	MINOXIDIL	Safeway	cc99123b-b1a3-4818-9a06-e64478871c16	2024-08-20	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	6277d0dc-ac63-4393-a8ef-5350d9808876	2024-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Elevate Hair Regrowth Treatment 5 Minoxidil Solution	MINOXIDIL	VAPOR PRO SHOPPE, LLC	12737299-1052-4c93-afab-20016b9d9001	2024-07-22	Warnings	Name fallback generic name: MINOXIDIL
kirkland signature minoxidil	MINOXIDIL	Costco Wholesale Company	010ca7df-1e79-44ea-9171-b9d239f141e1	2024-07-18	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (for Women)	MINOXIDIL	SCIENTIFIC HAIR RESEARCH, LLC	19603dd4-2099-479d-9e6e-14c5d1c49928	2024-07-03	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (for Men)	MINOXIDIL	SCIENTIFIC HAIR RESEARCH, LLC	5b8fe2d9-c7c5-4563-82f2-3d6bff08b830	2024-07-03	Warnings	Name fallback generic name: MINOXIDIL
minoxidil topical	MINOXIDIL	H E B	c9da0a80-2737-4e36-bbef-f7c4ae046ad7	2024-06-25	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Men)	MINOXIDIL	TARGET Corporation	5505e1b2-8c9b-457c-8291-cb8a9c1f6b10	2024-05-17	Warnings	Name fallback generic name: MINOXIDIL
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8cd4a3a9-94ba-48c7-8516-b50504c2c440	2024-05-16	Warnings	Name fallback generic name: MINOXIDIL
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8b81a5e5-315e-4b7d-8ffd-623382294d8a	2024-05-16	Warnings	Name fallback generic name: MINOXIDIL
minoxidil	MINOXIDIL	H E B	a05bc954-d369-4eb6-8a7d-d68955af874f	2024-05-13	Warnings	Name fallback generic name: MINOXIDIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8740	ORIG	2004-06-09
30960	ORIG	2000-11-17