Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079183
Company: HOSPIRA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/15/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/079183s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/17/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091594 ACCORD HLTHCARE
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079160 ACTAVIS TOTOWA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202997 DR REDDYS LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090242 FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090799 FRESENIUS KABI USA
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 079183 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200145 MYLAN LABS LTD

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