PREZISTA - 59676-565-01 - (darunavir)

Alphabetical Index


Drug Information of PREZISTA

Product NDC: 59676-565
Proprietary Name: PREZISTA
Non Proprietary Name: darunavir
Active Ingredient(s): 100    mg/mL & nbsp;   darunavir
Administration Route(s): ORAL
Dosage Form(s): SUSPENSION
Coding System: National Drug Codes(NDC)

Labeler Information of PREZISTA

Product NDC: 59676-565
Labeler Name: Janssen Products LP
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA202895
Marketing Category: NDA
Start Marketing Date: 20111216

Package Information of PREZISTA

Package NDC: 59676-565-01
Package Description: 200 mL in 1 BOTTLE, GLASS (59676-565-01)

NDC Information of PREZISTA

NDC Code 59676-565-01
Proprietary Name PREZISTA
Package Description 200 mL in 1 BOTTLE, GLASS (59676-565-01)
Product NDC 59676-565
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name darunavir
Dosage Form Name SUSPENSION
Route Name ORAL
Start Marketing Date 20111216
Marketing Category Name NDA
Labeler Name Janssen Products LP
Substance Name DARUNAVIR ETHANOLATE
Strength Number 100
Strength Unit mg/mL
Pharmaceutical Classes HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC]

Complete Information of PREZISTA


General Information