Home Applications 074731 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 Product TE source text RLD / RS 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 4 of 13 · 253 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 Name fallback generic name: MINOXIDIL equate hair regrowth treatment MINOXIDIL WALMART INC. fd67b4d2-e71d-4145-bf69-437d0aa86cd3 2026-05-12 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL CVS Pharmacy 57cd1b56-e120-488f-951a-26e447aa4657 2026-05-08 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment for men MINOXIDIL CVS Pharmacy f6320d33-92b1-44ef-97d8-56e78e83d417 2026-05-08 Warnings Name fallback generic name: MINOXIDIL RootVive Mens Hair Regrowth Treatment Extra Strength Minoxidil MINOXIDIL TrueRoot Labs LLC de865d37-d99f-4f9d-8c09-472a308e2e91 2026-05-06 Warnings Name fallback generic name: MINOXIDIL Mens Extra Strength Minoxidil Hair Growth Treatment MINOXIDIL Hairmax International, LLC 7ee426fe-7a13-4327-b333-9651d6871a73 2026-04-30 Warnings Name fallback generic name: MINOXIDIL Hair Growth Serum Roll-ON MINOXIDIL FlexiGo Inc 506c0a1b-b461-d535-e063-6294a90a4d20 2026-04-27 Warnings Name fallback generic name: MINOXIDIL BYNISEP 5% MINOXIDIL HAIR GROWTH SERUM MINOXIDIL Putian Licheng District Zhijiancheng Trading Co., Ltd. 5009b231-23c3-7356-e063-6394a90a569f 2026-04-22 Warnings Name fallback generic name: MINOXIDIL MINOXIDIL FOR WOMEN MINOXIDIL CARDINAL HEALTH 110, LLC. DBA LEADER 33f9e0de-dff1-4a14-8aec-8c842bf34c31 2026-04-13 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Bryant Ranch Prepack f76f6a05-11f8-48a6-98a3-b1407c228089 2026-04-13 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL MINOXIDIL FOR MEN MINOXIDIL CARDINAL HEALTH 110, LLC. DBA LEADER a592317d-bc7c-4c69-a3bf-74d57cd36e3a 2026-04-13 Warnings Name fallback generic name: MINOXIDIL up and up hair regrowth treatment for men MINOXIDIL Target Corporation 545e3e21-6333-4d85-8754-b7a6201234b7 2026-04-09 Warnings Name fallback generic name: MINOXIDIL Minoxidil (For Women) MINOXIDIL CVS Pharmacy b10eb8fd-8301-4c38-af4c-220fe5c3b592 2026-04-06 Warnings Name fallback generic name: MINOXIDIL Minoxidil (For Men) MINOXIDIL CVS Pharmacy f6d90382-dc51-480c-a46c-bad041915d07 2026-04-06 Warnings Name fallback brand name: Minoxidil (For Men) generic name: MINOXIDIL TAGOQHIA Minoxidil Hair Thickening Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4e8a913d-8c47-5948-e063-6394a90ad874 2026-04-03 Warnings Name fallback generic name: MINOXIDIL good sense hair regrowth treatment MINOXIDIL L. Perrigo Company 90e55b8a-11db-48b2-b2a0-48fd8870714d 2026-03-30 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL Meijer Distribution Inc a8a2b3c1-ecda-4fc9-b3fd-bb94cfee6e80 2026-03-25 Warnings Name fallback generic name: MINOXIDIL Minoxidil For Women MINOXIDIL BosleyMD ebda6e49-140c-4ab0-b155-5ed501ef3e8a 2026-03-24 Warnings Name fallback generic name: MINOXIDIL Tacruitf 5% minoxidil with biotin topical solution MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4dc2850a-9a7e-660f-e063-6294a90afd94 2026-03-24 Warnings Name fallback generic name: MINOXIDIL AGIKENB 5% minoxidil with biotin topical solution MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4dc2be0b-59f1-50fd-e063-6294a90a6f54 2026-03-24 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