Home Applications 075598 Application 075598
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL SOLUTION;TOPICAL 5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) MINOXIDIL 5% SOLUTION / TOPICAL 2001-06-13
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 2 of 2 · 44 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 2022-10-28 04:53 UTC 2022-10 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A075598-001 MINOXIDIL EXTRA STRENGTH (FOR MEN) 5% SOLUTION / TOPICAL 2001-06-13 a50c72e98297…
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 2 · 22 matching rows.
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 2 · 96 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0798 Good Sense Hair Regrowth Treatment Minoxidil L. Perrigo Company ANDA Current 0113-0798 Good Sense Hair Regrowth Treatment Minoxidil L. Perrigo Company ANDA Current 0113-1032 Good Sense Hair Regrowth Treatment minoxidil L. Perrigo Company ANDA Current 0113-1032 Good Sense Hair Regrowth Treatment minoxidil L. Perrigo Company ANDA Current 0113-7032 basic care hair regrowth treatment minoxidil L. Perrigo Company ANDA Current 0113-7798 Basic Care Hair Regrowth Minoxidil L. Perrigo Company ANDA Current 0113-7798 Basic Care Hair Regrowth Minoxidil L. Perrigo Company ANDA Current 0113-7798 Basic Care Hair Regrowth Minoxidil L. Perrigo Company ANDA Current 0363-0032 hair regrowth treatment minoxidil Walgreen Company ANDA Current 0363-0032 hair regrowth treatment minoxidil Walgreen Company ANDA Current 0363-0032 hair regrowth treatment minoxidil Walgreen Company ANDA Current 0363-0798 minoxidil Minoxidil Walgreen Company ANDA Current 0363-2798 hair regrowth treatment Minoxidil Walgreen Company ANDA Current 0363-2798 hair regrowth treatment Minoxidil Walgreen Company ANDA Current 11509-0798 just for men minoxidil Minoxidil Combe Incorporated ANDA Current 11509-0798 just for men minoxidil Minoxidil Combe Incorporated ANDA Current 11673-317 up and up hair regrowth treatment for men minoxidil Target Corporation ANDA Current 11673-632 up and up hair regrowth treatment for men Minoxidil Target Corporation ANDA Current 11673-632 up and up hair regrowth treatment for men Minoxidil Target Corporation ANDA Current 11673-632 up and up hair regrowth treatment for men Minoxidil Target Corporation ANDA Current 11673-798 up and up hair regrowth treatment for men Minoxidil Target Corporation ANDA Current 11822-0798 minoxidil Minoxidil Rite Aid Corporation ANDA Current 11822-0798 minoxidil Minoxidil Rite Aid Corporation ANDA Current 11822-0798 minoxidil Minoxidil Rite Aid Corporation ANDA Current 11822-0798 minoxidil Minoxidil Rite Aid Corporation ANDA Current 11822-1033 minoxidil minoxidil Rite Aid Corporation ANDA Current 11822-1260 hair regrowth treatment minoxidil Rite Aid Corporation ANDA Current 21130-273 signature care hair regrowth treatment Minoxidil Safeway ANDA Current 21130-273 signature care hair regrowth treatment Minoxidil Safeway ANDA Current 21130-819 signature care hair regrowth treatment minoxidil Safeway ANDA Current 25280-006 Loesch Hair Regrowth Formula Minoxidil Loesch Laboratory Consultants, Inc. ANDA Current 25280-006 Loesch Hair Regrowth Formula minoxidil Loesch Laboratory Consultant, INC. ANDA Current 30142-632 hair regrowth treatment minoxidil Kroger Company ANDA Current 30142-798 Hair Regrowth Treatment Minoxidil Kroger Company ANDA Current 30142-798 Hair Regrowth Treatment Minoxidil Kroger Company ANDA Current 37808-798 minoxidil Minoxidil H E B ANDA Current 37808-798 minoxidil Minoxidil H E B ANDA Current 37808-833 minoxidil minoxidil H E B ANDA Current 41163-798 Equaline hair regrowth treatment Minoxidil Supervalu Inc ANDA Current 41163-798 Equaline hair regrowth treatment Minoxidil Supervalu Inc ANDA Current 41250-428 hair regrowth treatment minoxidil Meijer, Inc. ANDA Current 41250-798 Hair Regrowth Treatment Minoxidil Meijer Distribution Inc ANDA Current 41250-798 Hair Regrowth Treatment Minoxidil Meijer Distribution Inc ANDA Current 49035-746 equate hair regrowth treatment minoxidil Wal-Mart Stores Inc ANDA Current 49035-798 equate hair regrowth treatment Minoxidil Wal-Mart Stores Inc ANDA Current 49035-798 equate hair regrowth treatment Minoxidil Wal-Mart Stores Inc ANDA Current 49035-798 equate hair regrowth treatment Minoxidil Wal-Mart Stores Inc ANDA Current 49738-385 Smart Sense Hair Regrowth Minoxidil Kmart Corporation ANDA Current 56062-322 minoxidil minoxidil Publix Super Markets Inc ANDA Current 56062-798 Minoxidil Minoxidil Publix Super Markets Inc ANDA Current 56062-798 Minoxidil Minoxidil Publix Super Markets Inc ANDA Current 56062-798 Minoxidil Minoxidil Publix Super Markets Inc ANDA Current 59779-798 Hair regrowth Minoxidil CVS Pharmacy ANDA Current 59779-798 Hair regrowth Minoxidil CVS Pharmacy ANDA Current 59779-798 Hair regrowth Minoxidil CVS Pharmacy ANDA Current 63940-032 core values minoxidil minoxidil Harmon Stores Inc. ANDA Current 63940-582 Core Values Minoxidil Minoxidil Harmon Stores Inc. ANDA Current 63940-582 Core Values Minoxidil Minoxidil Harmon Stores Inc. ANDA Current 63940-798 harmon face values minoxidil Minoxidil Harmon Stores Inc. ANDA Current 63981-032 kirkland signature minoxidil minoxidil Costco Wholesale Company ANDA Current 63981-380 Kirkland Signature Minoxidil Minoxidil Costco Wholesale Company ANDA Current 63981-380 Kirkland Signature Minoxidil Minoxidil Costco Wholesale Company ANDA Current 63981-798 kirkland signature minoxidil Minoxidil Costco Wholesale Company ANDA Current 63981-798 kirkland signature minoxidil Minoxidil Costco Wholesale Company ANDA Current 63981-798 kirkland signature minoxidil Minoxidil Costco Wholesale Company ANDA Current 68196-032 members mark hair regrowth treatment minoxidil Sam's West Inc ANDA Current 68196-401 Members Mark Minoxidil Minoxidil Sam's West Inc ANDA Current 68196-823 members mark hair regrowth treatment Minoxidil Sam's West Inc ANDA Current 68196-823 members mark hair regrowth treatment Minoxidil Sam's West Inc ANDA Current 68391-302 berkley and jensen minoxidil minoxidil BJWC ANDA Current 69282-002 Nioxin Hair Regrowth Treatment Extra Strength for Men Minoxidil The Wella Corporation ANDA Current 69282-002 Nioxin Hair Regrowth Treatment Extra Strength for Men Minoxidil The Wella Corporation ANDA Current 69842-598 Hair Regrowth Treatment minoxidil CVS Pharmacy ANDA Current 69842-598 Hair Regrowth Treatment minoxidil CVS Pharmacy ANDA Current 71177-002 Nutrastim Minoxidil Pulsaderm Llc ANDA Current 71177-005 Nutrastim Minoxidil Pulsaderm Llc ANDA Current 71517-001 minoxidil solution minoxidil solution Nutrastim Hair LLC ANDA Current 71517-001 minoxidil solution minoxidil solution Nutrastim Hair LLC ANDA Current 71713-093 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current 71713-093 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 22487 ORIG 2015-07-22 8733 ORIG 2004-06-09 8734 ORIG 2001-06-13