Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 091199

TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE)
EQ 4MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: TOPOTECAN HYDROCHLORIDE
Proprietary Name: TOPOTECAN HYDROCHLORIDE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 4MG BASE/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A091199
Product Number: 001
Approval Date: Dec 1, 2010
Applicant Holder Full Name: TEYRO LABS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information