PREZISTA - 52125-613-02 - (darunavir)

Alphabetical Index


Drug Information of PREZISTA

Product NDC: 52125-613
Proprietary Name: PREZISTA
Non Proprietary Name: darunavir
Active Ingredient(s): 800    mg/1 & nbsp;   darunavir
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of PREZISTA

Product NDC: 52125-613
Labeler Name: REMEDYREPACK INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021976
Marketing Category: NDA
Start Marketing Date: 20130529

Package Information of PREZISTA

Package NDC: 52125-613-02
Package Description: 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-613-02)

NDC Information of PREZISTA

NDC Code 52125-613-02
Proprietary Name PREZISTA
Package Description 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-613-02)
Product NDC 52125-613
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name darunavir
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20130529
Marketing Category Name NDA
Labeler Name REMEDYREPACK INC.
Substance Name DARUNAVIR ETHANOLATE
Strength Number 800
Strength Unit mg/1
Pharmaceutical Classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]

Complete Information of PREZISTA


General Information