FDA.report

Application 040274

Type
ANDA
Sponsor
MYLAN

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATETABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0373HYDROXYCHLOROQUINE SULFATEHYDROXYCHLOROQUINE SULFATEMylan Pharmaceuticals Inc.ANDACurrent
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
0378-0373Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Pharmaceuticals Inc.ANDACurrent
42292-011Hydroxychloroquine SulfateHydroxychloroquine SulfateMylan Institutional Inc.ANDACurrent
71610-507Hydroxychloroquine SulfateHydroxychloroquine SulfateAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
62491SUPPL2020-04-08
62490SUPPL2020-04-08
17761ORIG2004-06-07
42607ORIG2003-07-31
7600ORIG1998-05-29