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 Safety Information 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… Alprostadil Injection0.5 mg/ml [803 KB] Bedford ANDA 74-815 Caverject (Alprostadil) Sterile Powder & Injection, Pharmacia & Upjohn NDA 20-379/S17, 20-755/S5 & 21-212/S2 9/2/03 9/9/03 Caverject (Alprostadil) Injection, Pharmacia & Upjohn NDA 21-212 6/11/02 6/17/02 6/12/02 8/8/02 Caverject (Alprostadil for Injection) Sterile Powder Pharmacia & Upjohn Co. NDA 20-379/S-011 1/15/02 2/7/02 Caverject (Alprostadil for Injection) Sterile Powder Pharmacia & Upjohn Co. NDA 20-379/S-009 ALPROSTADIL Injection 0.5MG/ML ALPROSTADIL Bedford 075196 ALPROSTADIL Injection 0.5MG/ML ALPROSTADIL Gensia Sicor 020379 ALPROSTADIL Injection 0.005MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 020755 ALPROSTADIL Injection 0.01MG/ML CAVERJECT PHARMACIA AND UPJOHN 021212 ALPROSTADIL Injection 0.01MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 020379 ALPROSTADIL Injection 0.01MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 020755 ALPROSTADIL Injection 0.02MG/ML CAVERJECT PHARMACIA AND UPJOHN 021212 ALPROSTADIL Injection 0.02MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 020379 ALPROSTADIL Injection 0.02MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 020379 ALPROSTADIL Injection 0.04MG/VIAL CAVERJECT PHARMACIA AND UPJOHN 018484 ALPROSTADIL Injection 0.5MG/ML PROSTIN VR PEDIATRIC PHARMACIA AND UPJOHN 020649 ALPROSTADIL Injection 0.01MG/VIAL EDEX SCHWARZ 020649 ALPROSTADIL Injection 0.01MG/VIAL EDEX SCHWARZ 020649 ALPROSTADIL Injection 0.02MG/VIAL EDEX SCHWARZ 020649 ALPROSTADIL Injection 0.02MG/VIAL EDEX SCHWARZ 020649 ALPROSTADIL Injection 0.04MG/VIAL EDEX SCHWARZ 020649 ALPROSTADIL Injection 0.04MG/VIAL EDEX SCHWARZ 020700 ALPROSTADIL Suppository; Urethral 0.125MG MUSE VIVUS | 020700 ALPROSTADIL Suppository; Urethral 0.25MG MUSE VIVUS | 020700 ALPROSTADIL Suppository; Urethral 0.5MG MUSE VIVUS | 020700 ALPROSTADIL Suppository; Urethral 1MG MUSE VIVUS | EDEX (alprostadil) injection, Schwarz 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 | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com