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… Ellence (epirubicin hydrochloride) Injection, 50 mg/25 mL & 200 mg/100 mL single-use vials, Pharmacia & Upjohn NDA 50-778/S3 & S4 4/3/03 4/18/03 Ellence (epirubicin hydrochloride), 50 mg/25 mL & 200 mg/100 mL single-use vials; Intravenous, Pharmacia & Upjohn NDA 50-778 9/15/99 9/24/99 9/24/99 1/30/03 Ellence Indication: Indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. | Ellence (epirubicin hydrochloride) injection, Pfizer, Efficacy Supplement w/Clinical Data to Support | Epirubicin Hydrochloride Injection, Mayne Pharma, Tentative Approval | Epirubicin Hydrochloride for Injection lyophilized, Mayne Pharma, Approval | Epirubicin Hydrochloride Injection, Mayne Pharma, Approval | Epirubicin Hydrochloride Injection, Bedford Labs, Approval | Epirubicin Hydrochloride Injection, Teva Parenteral, Approval | Epirubicin Hydrochloride Injection, Dabur Oncology, Approval | Epirubicin Hydrochloride Injection, Abraxis Pharma, ApprovalEpirubicin Hydrochloride Injection, Watson Labs, Approval | Epirubicin Hydrochloride Injection, GeneraMedix Inc., Approval | Epirubicin Hydrochloride Injection, Activis Totowa, 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