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FDA Drug information

Dutasteride

Read time: 1 mins
Marketing start date: 02 May 2024

Summary of product characteristics


Effective Time

20221105

Version

5

Spl Product Data Elements

Dutasteride Dutasteride DUTASTERIDE DUTASTERIDE BUTYLATED HYDROXYTOLUENE GELATIN GLYCERIN METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE ALCOHOL FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE PROPYLENE GLYCOL CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES AMMONIA WATER OPAQUE-WHITE Oblong Shaped 641

Application Number

ANDA204373

Brand Name

Dutasteride

Generic Name

Dutasteride

Product Ndc

70771-1347

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1347-3 in bottle of 30 capsules Dutasteride Capsules, 0.5 mg R x only 30 Capsules container label

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