Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211938
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTARABINE CYTARABINE 2GM/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
12/23/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CYTARABINE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTARABINE CYTARABINE 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 211938 GLAND PHARMA LTD
CYTARABINE CYTARABINE 2GM/VIAL INJECTABLE;INJECTION Prescription No AP 074245 WEST-WARD PHARMS INT

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