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FDA Drug information

Darunavir

Read time: 1 mins
Marketing start date: 04 Apr 2025
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Summary of product characteristics


Effective Time

20240429

Version

1

Spl Product Data Elements

Darunavir Darunavir DARUNAVIR DARUNAVIR FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE 1215 Darunavir Darunavir DARUNAVIR DARUNAVIR FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE beige colored 1217

Application Number

ANDA214085

Brand Name

Darunavir

Generic Name

Darunavir

Product Ndc

70771-1745

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1745-6 Darunavir tablets, 600 mg 60 Tablets Rx only NDC 70771-1746-3 Darunavir tablets, 800 mg 30 Tablets Rx only darunavir 600 mg Darunavir 800 mg

Drug section

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