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