Application 076239

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	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
A076239-001	THEROXIDIL	MINOXIDIL	5%	SOLUTION / TOPICAL			2004-08-24

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	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076239-001	THEROXIDIL	5%	SOLUTION / TOPICAL	2004-08-24	`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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minoxidil Extra Strength for Men	MINOXIDIL	Roman Health Ventures Inc.	a568aba1-1016-4380-e053-2a95a90a396d	2025-01-08	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239 ndc (product): 72484-095
Tomum Hair Growth Treatment For Men Minoxidil Unscented	MINOXIDIL	BELLEKA INC	4c0582a3-f2be-4e53-a174-12269f7ddad0	2024-12-04	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength	MINOXIDIL	ESALON.COM, LLC	69b01eab-df9f-4ae8-87e4-add18883874b	2024-11-05	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Elevate Hair Regrowth Treatment 5	MINOXIDIL	VAPOR PRO SHOPPE, LLC	0d5e4258-a58d-4378-9be8-631114588cdb	2024-10-31	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
DAVV Minoxidil Topical Solution Mens Hair Regrowth Treatment	MINOXIDIL	Good Manager Holdings Inc	16b36a38-72c3-4a19-a28c-757ae02e097a	2024-10-28	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Elevate Hair Regrowth Treatment 5 Minoxidil Solution	MINOXIDIL	VAPOR PRO SHOPPE, LLC	12737299-1052-4c93-afab-20016b9d9001	2024-07-22	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
GROWELL Mens Hair Regrowth Treatment 5 Minoxidil	MINOXIDIL	APIRA SCIENCE, INC.	8cd4a3a9-94ba-48c7-8516-b50504c2c440	2024-05-16	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
BOSLEY Minoxidil Topical Solution 5 (for men)	MINOXIDIL	Scientific Hair Research, LLC	90d96eb1-a478-42ce-9389-642c57bbf280	2024-05-01	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
BOSLEY Man 5 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	c692b47d-12c3-4225-9eee-b08ca76e4daa	2023-10-26	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
SUAVECITO 5% Minoxidil Solution	MINOXIDIL	SUAVECITO, INC.	a6d3c488-f943-4edf-9d6b-21a3dee92d78	2023-07-18	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239
Regenpure Precision	MINOXIDIL	Salonceuticals, Inc.	4a113921-b2a9-42cc-e054-00144ff8d46c	2017-03-06	Warnings	Exact identifier application applno (ANDA): 076239 application number: ANDA076239 ndc (product): 71290-813

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 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49539-001	5% Minoxidil Topical Solution	Minoxidil	AVACOR PRODUCTS, LLC	ANDA	Current
49539-001	5% Minoxidil Topical Solution	Minoxidil	AVACOR PRODUCTS, LLC	ANDA	Current
51326-160	Mens Minoxidil	Minoxidil	Topiderm, Inc.	ANDA	Current
54111-205	Hair Regrow	5% Minoxidil Topical Solution	Bentley Laboratories, LLC	ANDA	Current
57483-535	Regoxidine	Minoxidil	Innovus Pharmaceuticals Inc.	ANDA	Current
61355-570	Toppik Mens Hair Regrowth Treatment	Minoxidil	Spencer Forrest, Inc.	ANDA	Current
64760-602	MENS alopexy	minoxidil	Genesis Pharmaceutical, Inc.	ANDA	Current
65121-101	BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Women	MINOXIDIL	Pure Source, LLC	ANDA	Current
65121-102	BOSLEY PROFESSIONAL STRENGTH HAIR REGROWTH TREATMENT Regular Strength For Men	MINOXIDIL	Pure Source, LLC	ANDA	Current
69019-001	Mens pura dor Hair Loss MD	Minoxidil 5%	Vitals International Group	ANDA	Current
69113-002	Bosley MD Extra Strength for Men	Minoxidil 5%	Scientific Hair Research, LLC	ANDA	Current
69113-003	Bosley MD Extra Strength for Men	Minoxidil 5%	Scientific Hair Research, LLC	ANDA	Current
69188-001	Mens SPECTRAL UHP EXTRA STRENGTH HAIR REGROWTH TREATMENT	Minoxidil 5%	DS Healthcare Group, Inc.	ANDA	Current
70150-003	EXT Hair Regrowth Treatment for Men 5%	Minoxidil 5%	TTEM, LLC	ANDA	Current
70150-005	Rootly Extra Strength Hair Regrowth Treatment for Men	Minoxidil 5%	TTEM, LLC	ANDA	Current
70150-007	GROFULLY Mens Extra Strength Hair Regrowth Treatment	Minoxidil 5%	TTEM, Inc	ANDA	Current
70550-602	Thick Head Hair Regrowth Treatment for Men	Minoxidil 5%	THICK HEAD, LLC	ANDA	Current
70788-580	Regen	5% Minoxidil Topical Solution	Premium Distribution, LLC	ANDA	Current
71176-781	Capillus Hair Regrowth Treatment	MINOXIDIL	Capillus, Llc	ANDA	Current
71290-813	Regenpure Precision	MINOXIDIL	Salonceuticals, Inc.	ANDA	Current
71761-260	Barbiux balsamic tonic 5%	Minoxidil	Incredible Products, S.A. de C.V.	ANDA	Current
71804-704	MDhair Extra Strength hair regrowth treatment for Men	Minoxidil 5%	MDalgorithms, Inc	ANDA	Current
72484-095	Minoxidil	Minoxidil	Roman Health Ventures Inc.	ANDA	Current
72484-095	Minoxidil	Minoxidil	Roman Health Ventures Inc.	ANDA	Current
72484-095	Minoxidil	Minoxidil	Roman Health Ventures Inc.	ANDA	Current
72764-002	GOOD GUY Mens Hair Regrowth Treatment	Minoxidil	Brandable, Inc.	ANDA	Current
73237-002	AZELOMAX FORTE	Minoxidil 5%	TRILOGIC LTD	ANDA	Current
73237-002	AZELOMAX FORTE	Minoxidil 5%	TRILOGIC LTD	ANDA	Current
73277-001	Shapiro MD 5% Minoxidil Hair Regrowth Treatment for Men	Minoxidil	CONVERSION LABS PR, LLC	ANDA	Current
73277-001	Shapiro MD 5% Minoxidil Hair Regrowth Treatment for Men	Minoxidil	CONVERSION LABS PR, LLC	ANDA	Current
73359-001	Club Roots - Topical Solution Hair Regrowth Treatment	Minoxidil 5%	Roots Hair Club, LLC	ANDA	Current
73359-001	Club Roots - Topical Solution Hair Regrowth Treatment	Minoxidil 5%	Roots Hair Club, LLC	ANDA	Current
73359-002	Roots Professional - Topical Solution Hair Regrowth Treatment	Minoxidil 5%	Roots Hair Club, LLC	ANDA	Current
73359-002	Roots Professional - Topical Solution Hair Regrowth Treatment	Minoxidil 5%	Roots Hair Club, LLC	ANDA	Current
73628-001	ScalpMED for Men - VITADIL-5A Hair Regrowth Treatment	Minoxidil 5%	Celmatrix Technologies, LLC	ANDA	Current
73628-001	ScalpMED for Men - VITADIL-5A Hair Regrowth Treatment	Minoxidil 5%	Celmatrix Technologies, LLC	ANDA	Current
73630-001	RIZE Hair Regrowth Treatment for Men 5%	Minoxidil 5%	Rize Health, LLC	ANDA	Current
73630-001	RIZE Hair Regrowth Treatment for Men 5%	Minoxidil 5%	Rize Health, LLC	ANDA	Current
74770-001	LamFun Hair Regrowth Treatment	Minoxidil	Shenzhen Lanfan Network Technology Co., Ltd.	ANDA	Current
81553-001	bourn Hair Regrowth Treatment for Men	Minoxidil 5%	Octri, Inc.	ANDA	Current
81553-001	bourn Hair Regrowth Treatment for Men	Minoxidil 5%	Octri, Inc.	ANDA	Current
81553-001	bourn Hair Regrowth Treatment for Men	Minoxidil 5%	Octri, Inc.	ANDA	Current
81632-001	Mens Intelligent Hair Regrowth Treatment	Minoxidil 5%	Intelligent Elephant LLC.	ANDA	Current
81632-001	Mens Intelligent Hair Regrowth Treatment	Minoxidil 5%	Intelligent Elephant LLC.	ANDA	Current
81718-001	myhair hair regrowth treatment	Minoxidil 5%	APV Life Sciences, LLC	ANDA	Current
81718-001	myhair hair regrowth treatment	Minoxidil 5%	APV Life Sciences, LLC	ANDA	Current
82524-002	Navi Hair Solutions Mens Hair Regrowth Treatment	Minoxidil 5%	United Distribution of MD, LLC	ANDA	Current
82545-002	Daniel Alain Extra Strength Hair Regrowth Treatment for Men	Minoxidil 5%	Daniel Alain, Inc	ANDA	Current
82987-101	THAPPINK HAIR GROWTH SERUM	Minoxidil	Shenzhen Tianzhu Fragrance Co., Ltd	ANDA	Current
83121-001	Peak Body Mens Hair Regrowth Treatment	Minoxidil 5%	Securemedical, Inc.	ANDA	Current