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 10 of 13 · 253 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join hims hair regrowth treatment MINOXIDIL Hims Inc c3caf0cd-9148-4696-9cb8-ec93cab3f9f5 2025-02-05 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL Meijer, Inc. 847ec102-ee04-4168-9b85-c66bb01a1161 2025-02-05 Warnings Name fallback generic name: MINOXIDIL kirkland signature minoxidil MINOXIDIL Costco Wholesale Company ec4b79fd-f68b-4f8d-a173-983835bc82eb 2025-02-04 Warnings Name fallback generic name: MINOXIDIL Minoxidil Extra Strength for Men MINOXIDIL Roman Health Ventures Inc. 03738dd6-a42c-0986-e063-6294a90a1cc0 2025-01-30 Warnings Name fallback generic name: MINOXIDIL SOLUCION CAPILAR CRECEPELO MINOXIDIL BOE Dominicana SRL 3d493e10-9cd9-6e2b-e063-6294a90a6d6c 2025-01-28 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Walgreens a08edb99-3e45-4d3c-a0f8-c74bd291057a 2025-01-28 Warnings Name fallback generic name: MINOXIDIL HAIR BEARDGROWTH FOAM MINOXIDIL Shenzhen Xuemin E-commerce Co., Ltd. 2bcf1d90-8936-117a-e063-6294a90a2468 2025-01-16 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Serum MINOXIDIL Shenzhen Shangmei Tiantianbaodan E-commerce Co., Ltd 2bba416c-b5ec-53fa-e063-6294a90a5d9e 2025-01-15 Warnings Name fallback generic name: MINOXIDIL Stafenit Hair Regrowth Treatment Topical Minoxidil MINOXIDIL Cozesmo cd74cc10-6df4-47bf-885e-333244db6d82 2025-01-09 Warnings Name fallback generic name: MINOXIDIL Minoxidil Extra Strength for Men MINOXIDIL Roman Health Ventures Inc. a568aba1-1016-4380-e053-2a95a90a396d 2025-01-08 Warnings Name fallback generic name: MINOXIDIL 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 Name fallback generic name: MINOXIDIL Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented MINOXIDIL SANTO REMEDIO LLC cfc7adf1-627b-41e1-b51a-cdcd8a14e796 2024-12-18 Warnings Name fallback generic name: MINOXIDIL Minoxidil (for Men) MINOXIDIL RESTORATION HOLDINGS, LLC e18223ad-642e-81a5-e053-2a95a90a0752 2024-12-11 Warnings Name fallback brand name: Minoxidil (for Men) generic name: MINOXIDIL 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 Name fallback generic name: MINOXIDIL Tomum Hair Growth Treatment For Men Minoxidil Unscented MINOXIDIL BELLEKA INC 4c0582a3-f2be-4e53-a174-12269f7ddad0 2024-12-04 Warnings Name fallback generic name: MINOXIDIL Womens Rogaine Unscented MINOXIDIL Kenvue Brands LLC 4d328537-b7f5-43cc-9837-c5a0c6c390f8 2024-11-13 Warnings Name fallback generic name: MINOXIDIL Mens rogaine Minoxidil Unscented Formula MINOXIDIL Kenvue Brands LLC 1b5e2860-6855-4a65-8bbc-e064172a1adf 2024-11-11 Warnings Name fallback generic name: MINOXIDIL Colorsmith Hair Regrowth Treatment Mens Minoxidil Topical Solution Extra Strength MINOXIDIL ESALON.COM, LLC 69b01eab-df9f-4ae8-87e4-add18883874b 2024-11-05 Warnings Name fallback generic name: MINOXIDIL eSalon Hair Regrowth Treatment Womens Minoxidil MINOXIDIL ESALON.COM, LLC c3951cc3-83c1-4d9d-8fbe-db6f1fb3986c 2024-11-05 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL P & L Development, LLC 59e7cdae-6595-4aa2-8fe0-7a8bcf300912 2024-11-05 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