FDA.reportPublic FDA data

Application 075518

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MINOXIDIL EXTRA STRENGTH (FOR MEN)MINOXIDILSOLUTION;TOPICAL5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9971MinoxidilMinoxidilWalgreensANDACurrent
0363-9973MinoxidilMinoxidilWalgreensANDACurrent
0472-0094MinoxidilMinoxidilActavis Pharma, Inc.ANDACurrent
0472-0094Hair Regrowth Treatment For MenminoxidilActavis Pharma, Inc.ANDACurrent
0472-0094MinoxidilMinoxidilActavis Pharma, Inc.ANDACurrent
55301-094Hair Regrowth Treatment for MenminoxidilArmy and Air Force Exchange ServiceANDACurrent
55301-094MinoxidilMinoxidilAAFES/Your Military ExchangesANDACurrent
55301-094MinoxidilMinoxidilArmy and Air Force Exchange ServiceANDACurrent
61269-094MinoxidilMinoxidilH2-Pharma, LLCANDACurrent
68016-382Minoxidil Form MenMinoxidilChain Drug Consortium, LLCANDACurrent
68016-382MinoxidilMinoxidilChain Drug Consortium, LLCANDACurrent
68016-382MinoxidilMinoxidilChain Drug Consortium, LLCANDACurrent
68016-382MinoxidilMinoxidilChain Drug Consortium, LLCANDACurrent
70550-503Minoxidil For MenMinoxidilAtlantic Coast Media Group, LLCANDACurrent
70550-503Minoxidil For MenMinoxidilAtlantic Coast Media Group, LLCANDACurrent
71730-042himsMinoxidil 5%Clubroom, Inc.ANDACurrent
72484-094MinoxidilMinoxidilRoman Health Ventures Inc.ANDACurrent
72484-094MinoxidilMinoxidilRoman Health Ventures Inc.ANDACurrent
72484-094Minoxidil Form MenMinoxidilRoman Health Ventures Inc.ANDACurrent
72484-094MinoxidilMinoxidilRoman Health Ventures Inc.ANDACurrent
72484-094MinoxidilMinoxidilRoman Health Ventures Inc.ANDACurrent
72882-094MinoxidilMinoxidilMens LLCANDACurrent
72882-094MinoxidilMinoxidilMens LLCANDACurrent
82269-607Hair Regrowth TreatmentMinoxidilSeiseidou America, Inc.ANDACurrent
82269-607Hair Regrowth TreatmentMinoxidilSeiseidou America, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8704ORIG2004-06-09
8705ORIG2000-11-17