|
|
| Line 3: |
Line 3: |
| {{CMG}}; {{AE}} {{AZ}} | | {{CMG}}; {{AE}} {{AZ}} |
|
| |
|
| ===HOW SUPPLIED===
| |
|
| |
|
| PREZISTA (darunavir) 100 mg/mL oral suspension is a white to off-white opaque liquid supplied in amber-colored multiple-dose bottles containing darunavir ethanolate equivalent to 100 mg of darunavir per mL packaged with a 6 mL oral dosing syringe with 0.2 mL gradations.
| |
|
| |
| PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with "75" on one side and "TMC" on the other side.
| |
|
| |
| PREZISTA (darunavir) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir per tablet. Each tablet is debossed with "150" on one side and "TMC" on the other side.
| |
|
| |
| PREZISTA (darunavir) 400 mg tablets are supplied as light orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 400 mg of darunavir per tablet. Each tablet is debossed with "400MG" on one side and "TMC" on the other side.
| |
|
| |
| PREZISTA (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir per tablet. Each tablet is debossed with "600MG" on one side and "TMC" on the other side.
| |
|
| |
| PREZISTA (darunavir) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir per tablet. Each tablet is debossed with "800" on one side and "T" on the other side.
| |
|
| |
| PREZISTA is packaged in bottles in the following configuration:
| |
|
| |
| 100 mg/mL oral suspension – 200 mL bottles (NDC 59676-565-01)
| |
|
| |
| 75 mg tablets—bottles of 480 (NDC 59676-563-01)
| |
|
| |
| 150 mg tablets—bottles of 240 (NDC 59676-564-01)
| |
|
| |
| 400 mg tablets—bottles of 60 (NDC 59676-561-01)
| |
|
| |
| 600 mg tablets—bottles of 60 (NDC 59676-562-01)
| |
|
| |
| 800 mg tablets—bottles of 30 (NDC 59676-566-30)
| |
| ==References== | | ==References== |
| {{Reflist}} | | {{Reflist}} |
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]
References
Adapted from the FDA Package Insert.