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 1 of 13 · 253 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL FlexiGo Inc 5406743a-b688-346e-e063-6294a90a2caf 2026-09-20 Warnings Name fallback generic name: MINOXIDIL HAIR REGROWTH TREATMENT MINOXIDIL Amazon.com Services LLC 0ce77e6b-c4cf-49e2-8fd9-183286c26f8a 2026-09-08 Warnings Name fallback generic name: MINOXIDIL EITIKO Minoxidil Hair Regrowth Treatment MINOXIDIL Guangzhou Ariel Medical Technology Co., Ltd. 5aa2a552-f8b5-f11a-e063-6394a90abb1a 2026-09-04 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Foam MINOXIDIL HONG KONG YUEJIE INTERNATIONAL TRADING LIMITED 5a7b2dec-4879-7491-e063-6394a90a874f 2026-09-02 Warnings Name fallback generic name: MINOXIDIL HAIR REGROWTH TREATMENT MINOXIDIL Amazon.com Services LLC 728db7d9-3f38-4006-8024-018f0d9c96da 2026-08-31 Warnings Name fallback generic name: MINOXIDIL MINOXIDIL 5% (FOR MEN) MINOXIDIL Better Living Brands, LLC 53e33414-2aa4-3dbd-e063-6294a90a06b5 2026-08-27 Warnings Name fallback generic name: MINOXIDIL MINOXIDIL 5% TOPICAL AEROSOL60g MINOXIDIL Shenzhen Joyuflsh Technology Co.,Ltd. 5a03675b-0bfd-7058-e063-6294a90acf4d 2026-08-27 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Walgreens 97d4d3ce-316c-4d58-b4dc-28d662b0fb4a 2026-08-27 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL American Health Packaging 0b4fc036-9497-442b-b629-c4b386932789 2026-08-25 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL Minoxidil Hair Regrowth Treatment MINOXIDIL Shenzhen Earth Surface Trading Co., Ltd. 59b4f9e3-c241-6a70-e063-6294a90a364f 2026-08-23 Warnings Name fallback generic name: MINOXIDIL Minoxidil Hair Regrowth Treatment MINOXIDIL Shenzhen Earth Surface Trading Co., Ltd. 59b52a52-dab0-87b5-e063-6294a90a0596 2026-08-23 Warnings Name fallback generic name: MINOXIDIL Minoxidil Hair Regrowth Treatment MINOXIDIL Shenzhen Earth Surface Trading Co., Ltd. 59b67ce0-3546-c18a-e063-6394a90ae50a 2026-08-23 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil hair growth Serum MINOXIDIL Guangzhou Huanmei Cosmetics Co., Ltd. 597582b0-cfcc-f7b7-e063-6394a90a0e9a 2026-08-20 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Bryant Ranch Prepack 75b2832c-0a6c-4125-9514-19a6d8dbf6cf 2026-08-20 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Bryant Ranch Prepack 8ccd07ab-07ed-4b42-b182-3d22b98abca7 2026-08-20 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL KIRKLAND SIGNATURE MINOXIDIL MINOXIDIL Costco Wholesale Company 90137bb7-f0e3-4c3c-9cfb-d4d5eed13a9c 2026-08-20 Warnings Name fallback generic name: MINOXIDIL apgwgzminoxidil5% MINOXIDIL Guangdong Jiaoyu Biotechnology Co., Ltd 596d0b43-5cb1-be25-e063-6394a90abbed 2026-08-19 Warnings Name fallback generic name: MINOXIDIL apgwgzminoxidil2% MINOXIDIL Guangdong Jiaoyu Biotechnology Co., Ltd 5957c990-e274-6278-e063-6394a90af2b7 2026-08-18 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Keranique 4af782f4-68d5-4338-a0a6-85d11a23ce98 2026-08-18 Warnings Name fallback generic name: MINOXIDIL Olivita Extra Strength Minoxidil MINOXIDIL Olivita Beauty Inc b2da549b-eb79-46ed-aaec-87326c4a1fbe 2026-08-17 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