FDA.reportPublic FDA data

Application 074731

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOXIDIL (FOR MEN)MINOXIDILSOLUTION;TOPICAL2%NoNo
002MINOXIDIL (FOR WOMEN)MINOXIDILSOLUTION;TOPICAL2%NoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074731-001MINOXIDIL (FOR MEN)MINOXIDIL2%SOLUTION / TOPICAL1996-12-24
A074731-002MINOXIDIL (FOR WOMEN)MINOXIDIL2%SOLUTION / TOPICAL2005-05-11

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MINOXIDIL (FOR MEN)MINOXIDILFlexiGo Inc5406743a-b688-346e-e063-6294a90a2caf2026-06-11WarningsName fallback
MINOXIDIL (FOR MEN)MINOXIDILFlexiGo Inc53793182-8a03-1b0f-e063-6294a90acca62026-06-04WarningsName fallback
Minoxidil (For Men)MINOXIDILCVS Pharmacyf6d90382-dc51-480c-a46c-bad041915d072026-04-06WarningsName fallback
Minoxidil (for Men)MINOXIDILRESTORATION HOLDINGS, LLCe18223ad-642e-81a5-e053-2a95a90a07522024-12-11WarningsName fallback
Minoxidil (for Men)MINOXIDILSCIENTIFIC HAIR RESEARCH, LLC5b8fe2d9-c7c5-4563-82f2-3d6bff08b8302024-07-03WarningsName fallback
Minoxidil (For Men)MINOXIDILTARGET Corporation5505e1b2-8c9b-457c-8291-cb8a9c1f6b102024-05-17WarningsName fallback
Minoxidil (For Men)MINOXIDILSPAZI INC.2b6abc4d-3596-4411-a9f8-77c338c99a5d2024-01-23WarningsName fallback
Minoxidil (For Men)MINOXIDILWalgreen Company39526f7d-5e39-4e2e-8689-94b76ddbc4622022-10-10WarningsName fallback

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

WARNINGS SECTION

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-001MinoxidilMinoxidilHi-Tech Pharmacal Co., Inc.ANDACurrent