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… ZOLPIDEM TARTRATE TABLET; ORAL 10MG AMBIEN SANOFI SYNTHELABO ZOLPIDEM TARTRATE TABLET; ORAL 5MG AMBIEN SANOFI SYNTHELABO Zolpidem Tartrate Tablets, 5 & 10 mg, Mylan ANDA 76-578 7/17/03 Zolpidem Tartrate Tablets, 5 & 10 mg, Par Pharmaceutical, ANDA 76-062 ZOLPIDEM TARTRATE Tablet; 10MG AMBIEN LOREX 019908 ZOLPIDEM TARTRATE Tablet; 5MG AMBIEN LOREX | Zolpidem Tartrate orally disintegrating tablets, Biovail Tech, Tentative Approval | Zolpidem Tartrate orally disintegrating tablets, TEVA Pharma, Tentative Approval | Zolpidem Tartrate Tablet, Caraco Pharma, Tentative Approval | Ambien CR (zolpidem tartrate) Extended-Release Tablets, Sanofi-Synthelabo, Approval | Zolpidem Tartrate Tablet, Pliva, Tentative Approval | Zolpidem Tartrate Tablet, Synthon Pharma, Tentative Approval | Zolpidem Tartrate Tablets, Mutual Pharma, Tentative Approval | Zolpidem Tartrate Tablet, Watson Laboratories, Tentative Approval | Zolpidem Tartrate Tablet, Apotex Inc., Tentative Approval | Zolpidem Tartrate Orally Disintegrating Tablets, Biovail Labs, Tentative Approval | Zolpidem Tartrate Tabelt, Cipla Ltd., Tentative Approval | Zolpidem Tartrate Tabelt, Genpharm Inc., Tentative Approval | Zolpidem Tartrate Tablets, Ranbaxy Labs, Tentative Approval | Ambien (zolpidem tartrate) Tablets, Sanofi-Aventis, Patient Population Altered | Zolpidem Tartrate Tablets, Mylan Pharma, Approval | Zolpidem Tartrate Tablets, Teva Pharma, Approval | Zolpidem Tartrate Tablets, Roxane Labs, Approval | Zolpidem Tartrate Tablets, Watson Labs, Approval | Zolpidem Tartrate Tablets, Ranbaxy Inc., Approval | Zolpidem Tartrate Tablets, Dr. Reddy’s Labs, Approval | Zolpidem Tartrate Tablets, Apotex, Approval | Zolpidem Tartrate Tablets, Synthon Pharma, Approval | Zolpidem Tartrate Tablets, Carlsbad Technology, Approval | Zolpidem Tartrate Tablets, Genpharm Inc., Approval | Zolpidem Tartrate Tablets, Mutual Pharma, Approval | Zolpidem Tartrate Tablets, Caraco Pharma, Approval | Zolpidem Tartrate Tablets, Sandoz Inc., Approval | Zolpidem Tartrate Tablets, Par Pharma, Approval | TOVALT ODT (zolpidem tartrate) Orally Disintegrating Tablets, Biovail Labs, Approval | Zolpidem Tartrate Tablet, Aurobindo Pharma, Approval | Zolpidem Tartrate Tablets, Wockhardt, Approval | Zolpidem Tartrate Tablet, Torrent Pharma, Approval | Zolpidem Tartrate Tablets, Invagen Pharma, Approval | Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo, Labeling Revision | Ambien CR (zolpidem tartrate) Tablets, Sanofi Aventis, New or Modified Indication | Zolpidem Tartrate Tablets, Hikma Pharmaceuticals, Approval | Ambien (zolpidem tartrate) Tablets, Sanofi-Synthelabo Research, Labeling Revision | Zolpidem Tartrate Tablets, Vintage Pharmaceuticals, LLC Approval ^ 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