Application 078176

Type: ANDA
Sponsor: EI INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THEROXIDIL	MINOXIDIL	SOLUTION;TOPICAL	2%	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
A078176-001	THEROXIDIL	MINOXIDIL	2%	SOLUTION / TOPICAL			2007-11-09

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	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A078176-001	THEROXIDIL	2%	SOLUTION / TOPICAL	2007-11-09	`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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foligain Professional Series Extra Strength for Women Minoxidil Topical Hair Regrowth Treatment	MINOXIDIL	WR Group, Inc.	a765cc59-ab59-4e49-ba28-926a2e0a78b1	2026-05-13	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
MDhair hair regrowth treatment for women	MINOXIDIL 2%	MDalgorithms, Inc	c3ba93d7-e826-f6ac-e053-2a95a90a7951	2026-04-24	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176 ndc (product): 71804-711
Minoxidil Topical Solution USP, 2%	MINOXIDIL 2%	Carol's Daughter, LLC	4d659f8f-b721-cf3b-e063-6394a90a50f6	2026-03-19	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Fete Health Hair Regrowth Treatment for Women	MINOXIDIL	Honest Pharma LLC	93f7a89b-65f1-4a58-af75-2eeb0e47a8f8	2026-02-11	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Womens MinoGrow Hair Regrowth Treatment Minoxidil	MINOXIDIL	Minogro Products, LLC	890c2acf-0c08-4c45-b29f-928b6155ca00	2026-02-03	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Happy Head Womens Hair Regrowth Treatment	MINOXIDIL	Happy Head, Inc	1e447c66-a8c9-42a4-94e9-b8739543834e	2025-09-24	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Gemachlich ZuHause Hair Growth Foam (Women)	HAIR GROWTH FOAM (WOMEN)	Guangdong Quadrant Ecological Technology Co., Ltd.	3af47ccf-dde0-4f8a-e063-6294a90a28d8	2025-07-27	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
REMIXDIL HAIR REGROWTH TREATMENT FOR WOMEN	MINOXIDIL 2%	Rida LLC	0d027e41-8acb-43c0-b9e4-4d3208dc7b37	2025-02-25	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented	MINOXIDIL	SANTO REMEDIO LLC	2a2d814f-d716-6e60-e063-6294a90aeb97	2024-12-26	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented	MINOXIDIL	SANTO REMEDIO LLC	cfc7adf1-627b-41e1-b51a-cdcd8a14e796	2024-12-18	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
The Root Of Goodness Healthy Growth Hair Regrowth System For Women 3 Step System	MINOXIDIL	Invest Strong, LLC	2e19bf51-1769-4bc1-9232-9aa4b8df5847	2024-12-05	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
eSalon Hair Regrowth Treatment Womens Minoxidil	MINOXIDIL	ESALON.COM, LLC	c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c	2024-11-05	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
KERANIQUE Hair Regrowth Treatment For Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	8d580c01-a13d-81f8-e053-2a95a90a7426	2024-08-22	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176 ndc (product): 70550-578
Keranique 2% Hair Regrowth Treatment for Women	MINOXIDIL	PROFECTUS BEAUTY, LLC	c781447a-10f1-70e3-e053-2995a90a40f8	2024-08-22	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176 ndc (product): 70550-576
GROWELL Womens Hair Regrowth Treatment 2 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8b81a5e5-315e-4b7d-8ffd-623382294d8a	2024-05-16	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
BOSLEY Minoxidil Topical Solution 2 for Women	MINOXIDIL	Scientific Hair Research, LLC	4fe1602f-797a-4469-b82c-3ade8a9c7fec	2024-02-21	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
BOSLEY Woman 2 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	a70d0bd4-ac02-4a55-b9e7-c20dfe830f08	2023-12-18	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176
Womens Minoxidil Hair Growth System	MINOXIDIL	Topiderm, Inc.	6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96	2021-04-23	Warnings	Exact identifier application applno (ANDA): 078176 application number: ANDA078176 ndc (product): 51326-161

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-2173	Solution	Minoxidil	Walgreens	ANDA	Current
0363-2173	Solution	Minoxidil	Walgreens	ANDA	Current
51326-161	Womens Minoxidil	Minoxidil	Topiderm, Inc.	ANDA	Current
57483-542	Regoxidine	Minoxidil	Innovus Pharmaceuticals Inc.	ANDA	Current
57483-542	Regoxidine	Minoxidil	Innovus Pharmaceuticals Inc.	ANDA	Current
61355-569	Toppik Womens Hair Regrowth Treatment	Minoxidil	Spencer Forrest, Inc.	ANDA	Current
64760-601	WOMENS alopexy	minoxidil	Genesis Pharmaceutical, Inc.	ANDA	Current
65121-562	KERANIQUE For Women Hair Regrowth Treatment	MINOXIDIL	Pure Source, LLC	ANDA	Current
65121-578	KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN	Minoxidil 2%	Pure Source, LLC	ANDA	Current
69113-001	Bosley MD Regular Strength for Women	Minoxidil 2%	Scientific Hair Research, LLC	ANDA	Current
69113-004	Bosley MD Regular Strength for Women	Minoxidil 2%	Scientific Hair Research, LLC	ANDA	Current
70150-001	EXT Hair Regrowth Treatment for Women	Minoxidil 2%	TTEM, LLC	ANDA	Current
70150-002	EXT Hair Regrowth Treatment for Men 2%	Minoxidil 2%	TTEM, LLC	ANDA	Current
70150-004	Rootly Hair Regrowth Treatment for Women	Minoxidil 2%	TTEM, LLC	ANDA	Current
70150-006	GROFULLY Womens Hair Regrowth Treatment	Minoxidil 2%	TTEM, Inc	ANDA	Current
70550-576	Keranique 2% Hair Regrowth Treatment for Women	Minoxodil 2%	Atlantic Coast Media Group, LLC	ANDA	Current
70550-576	Keranique 2% Hair Regrowth Treatment for Women	Minoxodil 2%	Profectus Beauty LLC	ANDA	Current
70550-578	Karanique Hair Regrowth Treatment For Women	Minoxidil 2%	INTERNATIONAL HAIR INSTITUTE	ANDA	Current
70550-578	KARANIQUE Hair Regrowth Treatment For Women	Minoxidil 2%	INTERNATIONAL HAIR INSTITUTE	ANDA	Current
70550-578	KERANIQUE Hair Regrowth Treatment For Women	Minoxidil 2%	INTERNATIONAL HAIR INSTITUTE	ANDA	Current
70550-578	KERANIQUE HAIR REGROWTH TREATMENT FOR WOMEN	Minoxidil 2%	PROFECTUS BEAUTY LLC	ANDA	Current
70788-579	Follinique	Minoxidil	Premium Distribution, LLC	ANDA	Current
71804-711	MDhair hair regrowth treatment for women	Minoxidil 2%	MDalgorithms, Inc	ANDA	Current
72484-085	Rory for Women	Minoxidil	Roman Health Ventures Inc.	ANDA	Current
72764-001	GROW GIRL	MINOXIDIL	Brandable, Inc.	ANDA	Current
73237-001	AXELOFEIN	Minoxidil 2%	TRILOGIC, LTD	ANDA	Current
73237-001	AXELOFEIN	Minoxidil 2%	TRILOGIC, LTD	ANDA	Current
73277-002	Shapriero 2% Hair Regrowth Treatment for Women	Minoxidil	CONVERSION LABS PR, LLC	ANDA	Current
73277-002	Shapriero 2% Hair Regrowth Treatment for Women	Minoxidil	CONVERSION LABS PR, LLC	ANDA	Current
73628-002	ScalpMED for Women - Vitadil-2A Hair Regrowth Treatment 2%	Minoxidil 2%	Celmatrix Technologies, LLC	ANDA	Current
73628-002	ScalpMED for Women - Vitadil-2A Hair Regrowth Treatment 2%	Minoxidil 2%	Celmatrix Technologies, LLC	ANDA	Current
82524-001	Navi Hair Solutions Womens Hair Regrowth Treatment	Minoxodil 2%	United Distribution of MD, LLC	ANDA	Current
82545-001	Daniel Alain Hair Regrowth Treatment for Women	Minoxidil 2%	Daniel Alain, Inc	ANDA	Current