Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205242
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription AP No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription AP No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) 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
12/06/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/03/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION; 200MG/5.26ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 200MG/5.26ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

INJECTABLE;INJECTION; 1GM/26.3ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

INJECTABLE;INJECTION; 2GM/52.6ML (38MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 204549 ACTAVIS INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 206776 APOTEX INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription Yes AP 200795 HOSPIRA INC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 210383 INGENUS PHARMS LLC
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 205242 MYLAN LABS LTD
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Prescription No AP 209077 SAGENT PHARMS

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