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 7 of 13 · 253 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RegrowthX Hair Regrowth Treatment Minoxidil MINOXIDIL Nimex Group Inc 77f70f47-8122-481c-b5f1-17e467f2c81b 2025-10-06 Warnings Name fallback generic name: MINOXIDIL Happy Head Mens Extra Strength Minoxidil MINOXIDIL Happy Head, Inc d3b4bc29-38c9-4180-a6d1-1ab1891897a2 2025-10-06 Warnings Name fallback generic name: MINOXIDIL aromatica hair gota de brillo romero con minoxidil MINOXIDIL LABORATORIO MK SRL 4032a965-844a-64a0-e063-6394a90ad26d 2025-10-02 Warnings Name fallback generic name: MINOXIDIL aromatica hair acondicionador romero con minoxidil MINOXIDIL LABORATORIO MK SRL 401f9960-e207-f489-e063-6394a90ad79d 2025-10-01 Warnings Name fallback generic name: MINOXIDIL aromatica hair tratamiento romero con minoxidil MINOXIDIL LABORATORIO MK SRL 40204efa-7be3-efd9-e063-6394a90acb0a 2025-10-01 Warnings Name fallback generic name: MINOXIDIL iBeaLee 5% Minoxidil Hair Regrowth Solution MINOXIDIL Shenzhen Earth Surface Trading Co., Ltd. 40001edd-d98c-4e2a-e063-6394a90a9911 2025-09-30 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Foam MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3feb9ac0-2cd1-9db2-e063-6394a90acab9 2025-09-29 Warnings Name fallback generic name: MINOXIDIL aromatica hair champu MINOXIDIL LABORATORIO MK SRL 3fb7dbd0-0eb9-cbee-e063-6294a90a63c2 2025-09-26 Warnings Name fallback generic name: MINOXIDIL Happy Head Womens Hair Regrowth Treatment MINOXIDIL Happy Head, Inc 1e447c66-a8c9-42a4-94e9-b8739543834e 2025-09-24 Warnings Name fallback generic name: MINOXIDIL Etaderm Mens Minoxidil Hair Regrowth Treatment Extra Strength MINOXIDIL NUEPHASE LLC fb838abf-43bf-4f7d-af78-18b7145946f4 2025-09-15 Warnings Name fallback generic name: MINOXIDIL 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin MINOXIDIL Shenzhen Ctrip Technology Co., Ltd. 1eae27bc-1b18-ae5d-e063-6394a90a4610 2025-09-12 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Foam with Biotin MINOXIDIL Shenzhen Ctrip Technology Co., Ltd. 21bb47c4-47c3-df7c-e063-6394a90abe15 2025-09-12 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Topical Solution MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3e569e69-55b9-1d01-e063-6294a90a88ed 2025-09-09 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Foam with Biotin MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3e5595a6-b36e-2567-e063-6294a90a2078 2025-09-08 Warnings Name fallback generic name: MINOXIDIL 5% Minoxidil Hair Growth Foam with Biotin MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 3e56352b-21ea-ce99-e063-6294a90a8066 2025-09-08 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL Proficient Rx LP a0066eac-cb58-49ef-a480-105cb1043c2b 2025-09-01 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL hair leave in MINOXIDIL LABORATORIO MK SRL 3cf686b8-01b6-98b3-e063-6294a90a59cb 2025-08-29 Warnings Name fallback generic name: MINOXIDIL hair growth solution MINOXIDIL LABORATORIO MK SRL 3c3f84da-c4bc-36ac-e063-6394a90aa8d1 2025-08-29 Warnings Name fallback generic name: MINOXIDIL hair treatment MINOXIDIL LABORATORIO MK SRL 3cf60fba-8c8d-d56f-e063-6294a90a344b 2025-08-29 Warnings Name fallback generic name: MINOXIDIL hair acondicionador MINOXIDIL LABORATORIO MK SRL 3cf543f6-d61e-f6f0-e063-6394a90a347a 2025-08-29 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