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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
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