Application 074731

Type: ANDA
Sponsor: HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MINOXIDIL (FOR MEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	No	No
002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	SOLUTION;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074731-001	MINOXIDIL (FOR MEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			1996-12-24
A074731-002	MINOXIDIL (FOR WOMEN)	MINOXIDIL	2%	SOLUTION / TOPICAL			2005-05-11

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 · 86 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	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074731-001	MINOXIDIL (FOR MEN)	2%	SOLUTION / TOPICAL	1996-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074731-002	MINOXIDIL (FOR WOMEN)	2%	SOLUTION / TOPICAL	2005-05-11	`74a2ff9319b5…`

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 12 of 13 · 253 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BOSLEY Minoxidil Topical Solution 5 (for men)	MINOXIDIL	Scientific Hair Research, LLC	90d96eb1-a478-42ce-9389-642c57bbf280	2024-05-01	Warnings	Name fallback generic name: MINOXIDIL
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	9d5e7acb-3892-4163-9f44-26e430959aa7	2024-04-23	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Women)	MINOXIDIL	TARGET Corporation	3a6bef39-1d8e-4ce3-9484-becd294566da	2024-04-16	Warnings	Name fallback generic name: MINOXIDIL
minoxidil	MINOXIDIL	L. Perrigo Company	ec91e5f2-f9c4-4a1d-a94c-3b7352339dab	2024-04-10	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Bryant Ranch Prepack	7aa8d272-0e44-43df-9263-9d84b2aa8946	2024-03-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Leader Minoxidil	MINOXIDIL	Cardinal Health 110, LLC. dba Leader	fbb17735-6c1f-44d6-865b-feec83a66b69	2024-03-04	Warnings	Name fallback generic name: MINOXIDIL
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	84759a4b-2bac-4daf-a07c-34f6ceb52c68	2024-02-22	Warnings	Name fallback generic name: MINOXIDIL
BOSLEY Minoxidil Topical Solution 2 for Women	MINOXIDIL	Scientific Hair Research, LLC	4fe1602f-797a-4469-b82c-3ade8a9c7fec	2024-02-21	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Men)	MINOXIDIL	SPAZI INC.	2b6abc4d-3596-4411-a9f8-77c338c99a5d	2024-01-23	Warnings	Name fallback brand name: Minoxidil (For Men) generic name: MINOXIDIL
Minoxidil (For Women)	MINOXIDIL	SPAZI INC.	facdb1c2-c36e-4bcc-a821-f8bad8bb17aa	2024-01-23	Warnings	Name fallback generic name: MINOXIDIL
MINOXIDIL	MINOXIDIL	Bryant Ranch Prepack	40da3ec5-39db-42f1-b0d6-39d852130307	2024-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
BOSLEY Woman 2 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	a70d0bd4-ac02-4a55-b9e7-c20dfe830f08	2023-12-18	Warnings	Name fallback generic name: MINOXIDIL
BOSLEY Man 5 Minoxidil Topical Solution	MINOXIDIL	Scientific Hair Research, LLC	c692b47d-12c3-4225-9eee-b08ca76e4daa	2023-10-26	Warnings	Name fallback generic name: MINOXIDIL
SUAVECITO 5% Minoxidil Solution	MINOXIDIL	SUAVECITO, INC.	a6d3c488-f943-4edf-9d6b-21a3dee92d78	2023-07-18	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil	MINOXIDIL	Proficient Rx LP	637718aa-a453-4acd-a992-590d637b63a3	2023-02-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MINOXIDIL
Regoxidine (For Men)	MINOXIDIL	Innovus Pharmaceuticals, Inc.	43b58fd3-81a7-4e64-81f3-9d9acfbf6819	2022-12-16	Warnings	Name fallback generic name: MINOXIDIL
Regoxidine (For Women)	MINOXIDIL	Innovus Pharmaceuticals, Inc.	b60cc177-700c-4007-be1a-2cb74824e657	2022-12-16	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil (For Women)	MINOXIDIL	Kroger Company	c443fadd-669e-4d29-8b11-ef3c022ca6f4	2022-10-25	Warnings	Name fallback generic name: MINOXIDIL
Minoxidil 5% (For Men)	MINOXIDIL	Kroger Company	8346788b-88b3-45c6-8c27-b34a810154fb	2022-10-24	Warnings	Name fallback generic name: MINOXIDIL
basic care hair regrowth treatment	MINOXIDIL	Amazon.com Services LLC	9fb42708-c6df-4d5e-907d-6ee232ef38da	2022-10-13	Warnings	Name fallback generic name: MINOXIDIL

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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current
50383-001	Minoxidil	Minoxidil	Hi-Tech Pharmacal Co., Inc.	ANDA	Current