PREZISTA - 59676-563-01 - (darunavir)

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Drug Information of PREZISTA

Product NDC: 59676-563
Proprietary Name: PREZISTA
Non Proprietary Name: darunavir
Active Ingredient(s): 75    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: 59676-563
Labeler Name: Janssen Products LP
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021976
Marketing Category: NDA
Start Marketing Date: 20090114

Package Information of PREZISTA

Package NDC: 59676-563-01
Package Description: 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)

NDC Information of PREZISTA

NDC Code 59676-563-01
Proprietary Name PREZISTA
Package Description 480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)
Product NDC 59676-563
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name darunavir
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20090114
Marketing Category Name NDA
Labeler Name Janssen Products LP
Substance Name DARUNAVIR ETHANOLATE
Strength Number 75
Strength Unit mg/1
Pharmaceutical Classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]

Complete Information of PREZISTA


General Information