Home Applications 091344 Application 091344
Type ANDA
Sponsor PERRIGO ISRAEL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MINOXIDIL MINOXIDIL AEROSOL, FOAM;TOPICAL 5% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091344-001 MINOXIDIL MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28
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 2 · 43 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 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091344-001 MINOXIDIL 5% AEROSOL, FOAM / TOPICAL 2011-04-28 f41ea6bd6efb…
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 · 23 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 2 of 2 · 113 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63981-294 kirkland signature Minoxidil Minoxidil Costco Wholesale Company ANDA Current 63981-294 kirkland signature Minoxidil Minoxidil Costco Wholesale Company ANDA Current 68196-023 members mark minoxidil Minoxidil Sam's West Inc ANDA Current 68196-469 members mark hair regrowth treatment Minoxidil Sam's West Inc ANDA Current 68196-469 members mark hair regrowth treatment Minoxidil Sam's West Inc ANDA Current 68196-469 members mark hair regrowth treatment Minoxidil Sam's West Inc ANDA Current 68391-294 berkley and jensen minoxidil Minoxidil BJWC ANDA Current 68391-294 berkley and jensen minoxidil Minoxidil BJWC ANDA Current 68391-294 berkley and jensen minoxidil Minoxidil BJWC ANDA Current 68391-294 berkley and jensen minoxidil Minoxidil BJWC ANDA Current 69423-586 Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Women Minoxidil The Procter & Gamble Manufacturing Company ANDA Current 69423-587 Head and Shoulders Scalp X Minoxidil Hair Regrowth Treatment for Men Minoxidil The Procter & Gamble Manufacturing Company ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 69842-599 hair regrowth treatment Minoxidil CVS Pharmacy ANDA Current 71713-092 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current 71713-092 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current 71713-092 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current 71713-092 keeps minoxidil topical Minoxidil THIRTY MADISON INC ANDA Current 71730-129 hers hair regrowth treatment Minoxidil Hims Inc ANDA Current 71730-129 hers hair regrowth treatment Minoxidil Hims Inc ANDA Current 71730-294 hims hair regrowth treatment Minoxidil Hims Inc ANDA Current 71730-294 hims hair regrowth treatment Minoxidil Hims Inc ANDA Current 71730-294 hims hair regrowth treatment Minoxidil Hims Inc ANDA Current 72288-129 basic care hair regrowth treatment Minoxidil Amazon.com Services LLC ANDA Current 72288-129 basic care hair regrowth treatment Minoxidil Amazon.com Services LLC ANDA Current 72288-129 basic care hair regrowth treatment Minoxidil Amazon.com Services LLC ANDA Current 72288-129 basic care hair regrowth treatment Minoxidil Amazon.com Services LLC ANDA Current 72288-294 Basic Care Hair Regrowth Treatment Minoxidil Amazon.com Services LLC ANDA Current 72288-294 Basic Care Hair Regrowth Treatment Minoxidil Amazon.com Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9333 ORIG 2011-05-03