Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 | Diprivan (propofol) Injection, APP Pharma, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com