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FDA Approval Activities for this Drug…
Diprivan (propofol) Injectable Emulsion,10 mg/mL, AstraZeneca LP NDA 19-627/S-35 Propofol Injectable Emulsion, 1% (10 mg/mL), (tentatively approved) Abbott ANDA 74-704 2/25/99 3/22/99 Propofol Injectable Emulsion, 1% (10 mg/mL), (tentatively approved) Baxter Pharmaceutical Products, ANDA 74-719 12/23/98 12/23/98 Propofol Injectable Emulsion, 1% (10 mg/mL), (tentatively approved)Full approval cannot be granted prior to March 22, 2015 Gensia Sicor ANDA 74-816 6/8/98 6/9/98 Propofol Injectable Emulsion, 1% (10 mg/mL), Gensia Sicor ANDA 75-102 1/4/99 7/11/01 Propofol Injectable Emulsion, 20 mL, pre-filled syringe, Gensia Sicor ANDA 75-392 9/19/00 10/30/00 8/6/03 Propofol Injectable Emulsion, 10 mg/mL, packaged in vials. (tentatively approved) ESI Lederle ANDA 75-040 PROPOFOL Injection 10MG/ML DIPRIVAN ASTRAZENECA 075392 PROPOFOL Injection 10MG/ML PROPOFOL Gensia Sicor 075102 PROPOFOL Injection 10MG/ML PROPOFOL Gensia Sicor | Propofol Injectable Emulsion, Bedford Labs, Approval | Propofol Injectable Emulsion, Hospira, Inc., Approval | Diprivan (propofol) Injectable Emulsion, Abraxis Bioscience, Labeling Revision
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