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 5 of 13 · 253 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Minoxidil For Men MINOXIDIL BosleyMD 61c41686-81af-4000-94bc-3cf9e71b0f18 2026-03-24 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL Meijer Distribution Inc cb6ca477-a626-4889-8d4c-62f06600ebbe 2026-03-19 Warnings Name fallback generic name: MINOXIDIL OLIVITA Minoxidil MINOXIDIL Shenzhen Xinxin Yunhai Technology Co., Ltd. 4cf37b0b-bbb8-1d9c-e063-6294a90af818 2026-03-13 Warnings Name fallback generic name: MINOXIDIL Verdibliss 5% Minoxidil Topical Hair Regrowth Treatment For Men MINOXIDIL Guangdong Quadrant Ecological Technology Co., Ltd. 4ca67652-4026-d647-e063-6394a90a34ed 2026-03-10 Warnings Name fallback generic name: MINOXIDIL 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4c92193d-8910-be62-e063-6294a90ae28e 2026-03-09 Warnings Name fallback generic name: MINOXIDIL Nizoral Hair Regrowth Treatment for Men MINOXIDIL Kramer Laboratories d3260777-d56a-4a35-ac82-b0e8e8021517 2026-03-04 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL P & L Development, LLC 204bab15-47c5-449c-a889-700914b04b61 2026-03-03 Warnings Name fallback generic name: MINOXIDIL Minoxidil MINOXIDIL P & L Development, LLC 04373c29-85f3-4d7d-bbdd-950dcf1a879a 2026-03-03 Warnings Name fallback generic name: MINOXIDIL NALIOPI 5% minoxidil with biotin topical solution MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4b9e16f0-3e39-03f2-e063-6394a90a19df 2026-02-24 Warnings Name fallback generic name: MINOXIDIL BEHATMH 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 4b9d581b-7133-5494-e063-6294a90a138c 2026-02-24 Warnings Name fallback generic name: MINOXIDIL GOOD SENSE HAIR REGROWTH TREATMENT MINOXIDIL L. Perrigo Company c5a23836-ddda-462a-9638-5dd488ea1588 2026-02-23 Warnings Name fallback generic name: MINOXIDIL VENANOCI Minoxidil MINOXIDIL Shenzhen Xinxin Yunhai Technology Co., Ltd. 4acc38aa-13da-981b-e063-6294a90aede5 2026-02-14 Warnings Name fallback generic name: MINOXIDIL Fete Health Hair Regrowth Treatment for Women MINOXIDIL Honest Pharma LLC 93f7a89b-65f1-4a58-af75-2eeb0e47a8f8 2026-02-11 Warnings Name fallback generic name: MINOXIDIL MINOXIDIL MINOXIDIL Sun Pharmaceutical Industries, Inc. 0354a7f5-5917-44dc-9963-411104008cb5 2026-02-09 Boxed warning, Warnings, Adverse reactions Name fallback generic name: MINOXIDIL Hair-Regen Hair Growth Treatment MINOXIDIL Yiwu Yizhou Trading Co., Ltd 1bdfebd0-cca8-1c8b-e063-6294a90a8792 2026-02-05 Warnings Name fallback generic name: MINOXIDIL hair regrowth treatment MINOXIDIL Meijer, Inc. 5cb0fe8a-996f-4bcf-8282-845ad6c6d819 2026-02-05 Warnings Name fallback generic name: MINOXIDIL Womens MinoGrow Hair Regrowth Treatment Minoxidil MINOXIDIL Minogro Products, LLC 890c2acf-0c08-4c45-b29f-928b6155ca00 2026-02-03 Warnings Name fallback generic name: MINOXIDIL TAGOQHIA 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 49d396bf-f427-7154-e063-6294a90a6043 2026-02-02 Warnings Name fallback generic name: MINOXIDIL TRZSFR 5% Minoxidil Hair Growth Sprays Serum MINOXIDIL Guangzhou Borderless Technology Co., Ltd. 49d40bf8-3ec1-347c-e063-6294a90a7450 2026-02-02 Warnings Name fallback generic name: MINOXIDIL 5% MINOXIDIL HAIR REGROWTH SERUM With Biotin MINOXIDIL Shenzhen Huayuan Hengsheng Technology Co., Ltd. 49e37010-3afe-119d-e063-6294a90ab74a 2026-02-02 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