Application 209074

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL (FOR MEN)	MINOXIDIL	AEROSOL, FOAM;TOPICAL	5%	No	No
002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	AEROSOL, FOAM;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209074-001	MINOXIDIL (FOR MEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2018-12-31
A209074-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	5%	AEROSOL, FOAM / TOPICAL			2019-04-22

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 3 · 84 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	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209074-001	MINOXIDIL (FOR MEN)	5%	AEROSOL, FOAM / TOPICAL	2018-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209074-002	MINOXIDIL (FOR WOMEN)	5%	AEROSOL, FOAM / TOPICAL	2019-04-22	`bb7c543d1eb4…`

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil	MINOXIDIL FOAM 5% (WOMENS)	Clarity Cosmetics Inc.	1b54eca8-4a96-1b5e-e063-6394a90a7b94	2026-05-08	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074
Minoxidil (For Women)	MINOXIDIL	CVS Pharmacy	b10eb8fd-8301-4c38-af4c-220fe5c3b592	2026-04-06	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 51316-213
Minoxidil (For Men)	MINOXIDIL	CVS Pharmacy	f6d90382-dc51-480c-a46c-bad041915d07	2026-04-06	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 51316-212
Minoxidil 5% (For Men)	MINOXIDIL	Sun Pharmaceutical Industries, Inc.	52210e2d-d87c-4b53-9b58-95c65c9d11fa	2026-03-10	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 51672-2128
Minoxidil For Women	MINOXIDIL	Sun Pharmaceutical Industries, Inc.	82d7a480-46b2-423b-8da0-a4fc252f7747	2026-03-10	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 51672-2129
Gemachlich ZuHause Hair Growth Foam (Men)	HAIR GROWTH FOAM (MEN)	Guangdong Quadrant Ecological Technology Co., Ltd.	3abe6f17-17ed-e25c-e063-6294a90a4d4d	2025-07-25	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074
Minoxidil (for Women)	MINOXIDIL	Virtue Labs, LLC	85a9d343-1135-4296-96b5-fabab6b834f9	2025-07-17	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 80855-201
Minoxidil (for Men)	MINOXIDIL	RESTORATION HOLDINGS, LLC	e18223ad-642e-81a5-e053-2a95a90a0752	2024-12-11	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 82796-100
Minoxidil (for Women)	MINOXIDIL	SCIENTIFIC HAIR RESEARCH, LLC	19603dd4-2099-479d-9e6e-14c5d1c49928	2024-07-03	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 69113-129
Minoxidil (for Men)	MINOXIDIL	SCIENTIFIC HAIR RESEARCH, LLC	5b8fe2d9-c7c5-4563-82f2-3d6bff08b830	2024-07-03	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 69113-128
Minoxidil (For Men)	MINOXIDIL	TARGET Corporation	5505e1b2-8c9b-457c-8291-cb8a9c1f6b10	2024-05-17	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 11673-157
Minoxidil (For Women)	MINOXIDIL	TARGET Corporation	3a6bef39-1d8e-4ce3-9484-becd294566da	2024-04-16	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 11673-158
Minoxidil (For Men)	MINOXIDIL	SPAZI INC.	2b6abc4d-3596-4411-a9f8-77c338c99a5d	2024-01-23	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 82376-6006
Minoxidil (For Women)	MINOXIDIL	SPAZI INC.	facdb1c2-c36e-4bcc-a821-f8bad8bb17aa	2024-01-23	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 82376-6007
Regoxidine (For Men)	MINOXIDIL	Innovus Pharmaceuticals, Inc.	43b58fd3-81a7-4e64-81f3-9d9acfbf6819	2022-12-16	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 57483-530
Regoxidine (For Women)	MINOXIDIL	Innovus Pharmaceuticals, Inc.	b60cc177-700c-4007-be1a-2cb74824e657	2022-12-16	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 57483-540
Minoxidil (For Women)	MINOXIDIL	Kroger Company	c443fadd-669e-4d29-8b11-ef3c022ca6f4	2022-10-25	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 59450-211
Minoxidil 5% (For Men)	MINOXIDIL	Kroger Company	8346788b-88b3-45c6-8c27-b34a810154fb	2022-10-24	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 59450-210
Minoxidil (For Men)	MINOXIDIL	Walgreen Company	39526f7d-5e39-4e2e-8689-94b76ddbc462	2022-10-10	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 0363-9090
Minoxidil (For Women)	MINOXIDIL	Walgreen Company	8a32828d-1591-478d-aed3-5159232675b4	2022-10-10	Warnings	Exact identifier application applno (ANDA): 209074 application number: ANDA209074 ndc (product): 0363-9091

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9090	Minoxidil	Minoxidil	Walgreen Company	ANDA	Current
0363-9091	Minoxidil	Minoxidil	Walgreen Company	ANDA	Current
11673-157	Minoxidil	Minoxidil	TARGET Corporation	ANDA	Current
11673-158	Minoxidil	Minoxidil	TARGET Corporation	ANDA	Current
51316-212	Minoxidil	Minoxidil	CVS Pharmacy	ANDA	Current
51316-213	Minoxidil	Minoxidil	CVS Pharmacy	ANDA	Current
51672-2128	Minoxidil	Minoxidil	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2128	Minoxidil	Minoxidil	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2128	Minoxidil	Minoxidil	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2129	Minoxidil	Minoxidil	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-2129	Minoxidil	Minoxidil	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
57483-530	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
57483-530	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
57483-530	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
57483-540	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
57483-540	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
57483-540	Regoxidine	Minoxidil	Innovus Pharmaceuticals, Inc.	ANDA	Current
59450-210	Minoxidil	Minoxidil	Kroger Company	ANDA	Current
59450-211	Minoxidil	Minoxidil	Kroger Company	ANDA	Current
69113-128	Minoxidil	Minoxidil	SCIENTIFIC HAIR RESEARCH, LLC	ANDA	Current
69113-129	Minoxidil	Minoxidil	SCIENTIFIC HAIR RESEARCH, LLC	ANDA	Current
70550-605	Minoxidil	Minoxidil	PROFECTUS BEAUTY LLC	ANDA	Current
71713-091	Minoxidil	Minoxidil	Thirty MADISON, Inc.	ANDA	Current
80855-201	Minoxidil	Minoxidil	Virtue Labs, LLC	ANDA	Current
82376-6006	Minoxidil	Minoxidil	SPAZI INC.	ANDA	Current
82376-6007	Minoxidil	Minoxidil	SPAZI INC.	ANDA	Current
82796-100	Minoxidil	Minoxidil	RESTORATION HOLDINGS, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
58292	ORIG	2019-04-11
57323	ORIG	2019-01-22