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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022453

TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE)
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: TOPOTECAN HYDROCHLORIDE
Proprietary Name: TOPOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: N022453
Product Number: 001
Approval Date: Dec 20, 2012
Applicant Holder Full Name: MEITHEAL PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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