Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203576
Company: MYLAN TEORANTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS Discontinued None No No
LEVOLEUCOVORIN CALCIUM LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) SOLUTION;INTRAVENOUS 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
10/20/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203576Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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