Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210383
Company: INGENUS PHARMS LLC
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 Discontinued None No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 1GM/26.3ML (38MG/ML) INJECTABLE;INJECTION Discontinued None No No
GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE 2GM/52.6ML (38MG/ML) INJECTABLE;INJECTION Discontinued None 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
02/14/2019 ORIG-1 Approval STANDARD

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