Home Applications 075357 Application 075357
Type ANDA
Sponsor L PERRIGO CO 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 1 .
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 A075357-001 MINOXIDIL (FOR MEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30 A075357-002 MINOXIDIL (FOR WOMEN) MINOXIDIL 2% SOLUTION / TOPICAL 1999-07-30
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075357-001 MINOXIDIL (FOR MEN) 2% SOLUTION / TOPICAL 1999-07-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A075357-002 MINOXIDIL (FOR WOMEN) 2% SOLUTION / TOPICAL 1999-07-30 782e0a99824c…
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 1 · 18 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 66 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-7202 basic care hair regrowth treatment minoxidil L. Perrigo Company ANDA Current 0113-7202 basic care hair regrowth treatment minoxidil L. Perrigo Company ANDA Current 0363-0703 hair regrowth treatment Minoxidil Walgreen Company ANDA Current 0363-7202 hair regrowth treatment minoxidil Walgreen Company ANDA Current 0363-7202 hair regrowth treatment minoxidil Walgreen Company ANDA Current 11673-189 up and up hair regrowth treatment for women Minoxidil Target Corporation ANDA Current 11673-189 up and up hair regrowth treatment for women Minoxidil Target Corporation ANDA Current 11673-382 up and up hair regrowth treatment for women minoxidil Target Corporation ANDA Current 11673-856 Up and Up minoxidil Minoxidil Target Corporation ANDA Current 11673-919 up and up hair regrowth treatment for women Minoxidil Target Corporation ANDA Current 11822-0202 Minoxidil minoxidil Rite Aid Corporation ANDA Current 11822-0202 Minoxidil minoxidil Rite Aid Corporation ANDA Current 11822-0702 minoxidil Minoxidil Rite Aid Corporation ANDA Current 25280-007 Loesch Hair Regrowth Formula minoxidil Loesch Laboratory Consultant, INC. ANDA Current 25280-007 Loesch Hair Regrowth Formula Minoxidil Loesch Laboratory Consultants, Inc. ANDA Current 30142-202 hair regrowth treatment minoxidil Kroger Company ANDA Current 30142-202 hair regrowth treatment minoxidil Kroger Company ANDA Current 37808-202 Minoxidil minoxidil H E B ANDA Current 37808-202 Minoxidil minoxidil H E B ANDA Current 41250-202 hair regrowth treatment minoxidil Meijer Distribution Inc ANDA Current 41250-202 hair regrowth treatment minoxidil Meijer Distribution Inc ANDA Current 41250-202 hair regrowth treatment minoxidil Meijer Distribution Inc ANDA Current 49035-202 equate hair regrowth treatment minoxidil Wal-Mart Stores Inc ANDA Current 49035-202 equate hair regrowth treatment minoxidil Wal-Mart Stores Inc ANDA Current 49035-202 equate hair regrowth treatment minoxidil Wal-Mart Stores Inc ANDA Current 49738-202 image essentials hair regrowth treatment minoxidil Kmart Corporation ANDA Current 49738-353 smart sense hair regrowth treatment minoxidil Kmart Corporation ANDA Current 56062-070 minoxidil Minoxidil Publix Super Markets Inc ANDA Current 56062-202 minoxidil minoxidil Publix Super Markets Inc ANDA Current 56062-202 minoxidil minoxidil Publix Super Markets Inc ANDA Current 56062-202 minoxidil minoxidil Publix Super Markets Inc ANDA Current 59640-000 minoxidil topical Minoxidil H E B ANDA Current 59779-202 hair regrowth minoxidil CVS Pharmacy ANDA Current 59779-202 hair regrowth minoxidil CVS Pharmacy ANDA Current 59779-202 hair regrowth minoxidil CVS Pharmacy ANDA Current 63940-202 harmon face values minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-202 harmon face values minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-202 harmon face values minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-491 Core Values Minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-491 Core Values Minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-509 core values minoxidil Minoxidil Harmon Stores Inc. ANDA Current 64942-2110 Michiru hair regrowth treatment for women Minoxidil Conopco Inc. d/b/a Unilever ANDA Current 69282-001 Nioxin Hair Regrowth Treatment for Women Minoxidil The Wella Corporation ANDA Current 69282-001 Nioxin Hair Regrowth Treatment for Women Minoxidil The Wella Corporation ANDA Current 69282-001 Nioxin Hair Regrowth Treatment for Women Minoxidil The Wella Corporation ANDA Current 69282-002 Nioxin Hair Regrowth Treatment Extra Strength for Men Minoxidil The Wella Corporation ANDA Current 69842-797 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 71730-202 hers minoxidil minoxidil Hims, Inc. ANDA Current 71730-202 hers minoxidil minoxidil Hims, Inc. ANDA Current 71730-202 hers minoxidil minoxidil Hims Inc ANDA Current 71730-202 hers minoxidil minoxidil Hims, Inc. ANDA Current 72288-202 basic care hair regrowth treatment minoxidil Amazon.com Services LLC ANDA Current 72288-701 basic care hair regrowth treatment Minoxidil Amazon.com Services LLC ANDA Current 78098-301 ELEVATE 5% MINOXIDIL FOAM ELEVATE 5% MINOXIDIL FOAM GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD ANDA Current 78098-302 Elevate 5% minoxidil liquid Elevate 5% minoxidil liquid GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD ANDA Current 78098-303 Elevate 5% minoxidil hair liquid Elevate 5% minoxidil hair liquid GUANGZHOU NODA PHARMACEUTICAL TECHNOLOGY INCORPORATED CO., LTD ANDA Current 79481-0070 hair regrowth treatment Minoxidil Meijer, Inc. ANDA Current 79903-072 equate hair regrowth treatment Minoxidil WALMART INC. ANDA Current 81653-001 BUNEE Hair Growth Serum Minoxidil Guangzhou Jianyuan Biological Technology Co., Ltd. ANDA Current 81653-002 ELEVATE HAIR GROWTH SERUM Minoxidil Guangzhou Jianyuan Biological Technology.Co.,Ltd ANDA Current 82157-002 Nioxin Hair Regrowth Treatment Minoxidil Wella Operations US LLC ANDA Current 82157-002 Nioxin Hair Regrowth Treatment Minoxidil Wella Operations US LLC ANDA Current 82157-002 Nioxin Hair Regrowth Treatment Minoxidil Wella Operations US LLC ANDA Current 82157-200 Nioxin Hair Regrowth Kit Minoxidil Wella Operations US LLC ANDA Current 82157-200 Nioxin Hair Regrowth Kit Minoxidil Wella Operations US LLC ANDA Current 82157-200 Nioxin Hair Regrowth Kit Minoxidil Wella Operations US LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 42982 ORIG 2015-07-21 8630 ORIG 1999-07-30