Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204406
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription None No No
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/06/2017 ORIG-1 Approval

Label is not available on this site.

TOPOTECAN HYDROCHLORIDE

SOLUTION;INTRAVENOUS; EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 204406 ACCORD HLTHCARE
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 200582 HOSPIRA INC
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 206074 MYLAN LABS LTD
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/4ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS Prescription No AP 022453 TEVA PHARMS USA

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