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FDA Drug information

Dutasteride and tamsulosin hydrochloride

Read time: 1 mins
Marketing start date: 05 May 2024
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Summary of product characteristics


Effective Time

20220812

Version

4

Spl Product Data Elements

Dutasteride and tamsulosin hydrochloride Dutasteride and tamsulosin hydrochloride DUTASTERIDE DUTASTERIDE TAMSULOSIN HYDROCHLORIDE TAMSULOSIN ALCOHOL AMMONIA BUTYL ALCOHOL BUTYLATED HYDROXYTOLUENE CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES CARRAGEENAN CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN GLYCERIN HYPROMELLOSES ISOPROPYL ALCOHOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER METHYLPARABEN POTASSIUM CHLORIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL PROPYLPARABEN SHELLAC TALC TITANIUM DIOXIDE TRIACETIN OPAQUE YELLOW CAP OPAQUE WHITE BODY CAPSULE 640

Application Number

ANDA207769

Brand Name

Dutasteride and tamsulosin hydrochloride

Generic Name

Dutasteride and tamsulosin hydrochloride

Product Ndc

70771-1356

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1356-3 Dutasteride and tamsulosin hydrochloride Capsules, 0.4/0.5 mg Rx only 30 Capsules Dutasteride and tamsulosin hydrochloride capsules

Drug section

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