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 8 of 13 · 253 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join hair champu MINOXIDIL LABORATORIO MK SRL 3ce73d95-3199-1ca3-e063-6394a90a2207 2025-08-29 Warnings Name fallback generic name: MINOXIDIL HAIR GROWTH FOAM MINOXIDIL Shenzhen Shandian Jingling Technology Co., Ltd. 3ceecb17-b013-f957-e063-6394a90ae2ed 2025-08-22 Warnings Name fallback generic name: MINOXIDIL ERWCNMIE 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3caf4291-15b5-cdba-e063-6394a90a1a0e 2025-08-18 Warnings Name fallback generic name: MINOXIDIL minoxidil MINOXIDIL Publix Super Markets Inc d0ff44ef-d59c-43c9-a381-448fef2cfe22 2025-08-12 Warnings Name fallback generic name: MINOXIDIL EZBIORT 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3c266bb4-baf3-9f79-e063-6294a90ac7a2 2025-08-12 Warnings Name fallback generic name: MINOXIDIL TAGOQHA 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3c267a04-d4fc-51b6-e063-6294a90a00a1 2025-08-12 Warnings Name fallback generic name: MINOXIDIL minoxidil MINOXIDIL Publix Super Markets Inc 57699890-6fef-4bd8-b690-161458131cd7 2025-08-12 Warnings Name fallback generic name: MINOXIDIL Trzsfr 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3b98c04d-1ff6-842e-e063-6294a90a6801 2025-08-05 Warnings Name fallback generic name: MINOXIDIL Minoxidil (for Women) MINOXIDIL Virtue Labs, LLC 85a9d343-1135-4296-96b5-fabab6b834f9 2025-07-17 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL Walgreen Company fb2a8bfe-7eae-4a78-a610-58c9e80adf72 2025-07-17 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil and 5% Rosemary for Hair Care MINOXIDIL TIKNOW LLC 1bb386d2-70c6-c487-e063-6294a90a19da 2025-07-07 Warnings Name fallback generic name: MINOXIDIL CYPKEB 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 371eb74f-b945-d1a8-e063-6394a90a8237 2025-06-09 Warnings Name fallback generic name: MINOXIDIL OCVWJKD 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 36e1cb29-cc4a-06cb-e063-6294a90a448a 2025-06-06 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Actavis Pharma, Inc. ab30461c-f8c8-409d-9e24-d58ed8a34873 2025-06-04 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL Sidinox 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 36a78022-f7ad-c6a3-e063-6294a90a0078 2025-06-03 Warnings Name fallback generic name: MINOXIDIL hims hair regrowth treatment MINOXIDIL Hims Inc f7d7bb41-acf3-4738-b466-2ed4204b068d 2025-06-02 Warnings Name fallback generic name: MINOXIDIL BLIYEOGZ 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 365706a2-f822-640e-e063-6294a90a35b1 2025-05-30 Warnings Name fallback generic name: MINOXIDIL AMRWRIR 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3608b948-e8f3-232a-e063-6294a90a1981 2025-05-26 Warnings Name fallback generic name: MINOXIDIL Hair Regrowth Treatment MINOXIDIL CVS Pharmacy 7041e548-e3ff-4623-8c35-783c64d5f04c 2025-05-22 Warnings Name fallback generic name: MINOXIDIL members mark hair regrowth treatment MINOXIDIL Sam's West Inc b3377092-b00d-4ab0-b62e-acd108dc330c 2025-05-22 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