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 7 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RegrowthX Hair Regrowth Treatment Minoxidil	MINOXIDIL	Nimex Group Inc	77f70f47-8122-481c-b5f1-17e467f2c81b	2025-10-06	Warnings	Name fallback generic name: MINOXIDIL
Happy Head Mens Extra Strength Minoxidil	MINOXIDIL	Happy Head, Inc	d3b4bc29-38c9-4180-a6d1-1ab1891897a2	2025-10-06	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair gota de brillo romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	4032a965-844a-64a0-e063-6394a90ad26d	2025-10-02	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair acondicionador romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	401f9960-e207-f489-e063-6394a90ad79d	2025-10-01	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair tratamiento romero con minoxidil	MINOXIDIL	LABORATORIO MK SRL	40204efa-7be3-efd9-e063-6394a90acb0a	2025-10-01	Warnings	Name fallback generic name: MINOXIDIL
iBeaLee 5% Minoxidil Hair Regrowth Solution	MINOXIDIL	Shenzhen Earth Surface Trading Co., Ltd.	40001edd-d98c-4e2a-e063-6394a90a9911	2025-09-30	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3feb9ac0-2cd1-9db2-e063-6394a90acab9	2025-09-29	Warnings	Name fallback generic name: MINOXIDIL
aromatica hair champu	MINOXIDIL	LABORATORIO MK SRL	3fb7dbd0-0eb9-cbee-e063-6294a90a63c2	2025-09-26	Warnings	Name fallback generic name: MINOXIDIL
Happy Head Womens Hair Regrowth Treatment	MINOXIDIL	Happy Head, Inc	1e447c66-a8c9-42a4-94e9-b8739543834e	2025-09-24	Warnings	Name fallback generic name: MINOXIDIL
Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength	MINOXIDIL	NUEPHASE LLC	fb838abf-43bf-4f7d-af78-18b7145946f4	2025-09-15	Warnings	Name fallback generic name: MINOXIDIL
5% MINOXIDIL HAIR REGROWTH SERUM With Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	1eae27bc-1b18-ae5d-e063-6394a90a4610	2025-09-12	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Shenzhen Ctrip Technology Co., Ltd.	21bb47c4-47c3-df7c-e063-6394a90abe15	2025-09-12	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Topical Solution	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e569e69-55b9-1d01-e063-6294a90a88ed	2025-09-09	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e5595a6-b36e-2567-e063-6294a90a2078	2025-09-08	Warnings	Name fallback generic name: MINOXIDIL
5% Minoxidil Hair Growth Foam with Biotin	MINOXIDIL	Guangzhou Borderless Technology Co., Ltd.	3e56352b-21ea-ce99-e063-6294a90a8066	2025-09-08	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Proficient Rx LP	a0066eac-cb58-49ef-a480-105cb1043c2b	2025-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
hair leave in	MINOXIDIL	LABORATORIO MK SRL	3cf686b8-01b6-98b3-e063-6294a90a59cb	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair growth solution	MINOXIDIL	LABORATORIO MK SRL	3c3f84da-c4bc-36ac-e063-6394a90aa8d1	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair treatment	MINOXIDIL	LABORATORIO MK SRL	3cf60fba-8c8d-d56f-e063-6294a90a344b	2025-08-29	Warnings	Name fallback generic name: MINOXIDIL
hair acondicionador	MINOXIDIL	LABORATORIO MK SRL	3cf543f6-d61e-f6f0-e063-6394a90a347a	2025-08-29	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