Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077139
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE;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
09/21/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/14/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/077139Orig1s016ltr.pdf
06/06/2011 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/14/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077139Orig1s016lbl.pdf

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