Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091199
Company: CIPLA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION 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
12/01/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/26/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/16/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

TOPOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 4MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYCAMTIN TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 020671 NOVARTIS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202351 ACCORD HLTHCARE
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090620 ACTAVIS TOTOWA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091199 CIPLA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201191 DR REDDYS LABS LTD
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091089 FRESENIUS KABI USA
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201166 HONG KONG
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206962 NOVAST LABS
TOPOTECAN HYDROCHLORIDE TOPOTECAN HYDROCHLORIDE EQ 4MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091284 SAGENT PHARMS

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