Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206263
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;IV (INFUSION) 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
06/16/2016 ORIG-1 Approval STANDARD Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206263Orig1s000lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/16/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206263Orig1s000lbl.pdf

LEVOLEUCOVORIN CALCIUM

POWDER;IV (INFUSION); EQ 50MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FUSILEV LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;IV (INFUSION) Prescription Yes AP 020140 SPECTRUM PHARMS
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;IV (INFUSION) Prescription No AP 206516 ACTAVIS LLC
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;IV (INFUSION) Prescription No AP 207547 AMNEAL PHARMS CO
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL POWDER;IV (INFUSION) Prescription No AP 206263 WEST-WARD PHARMS INT

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