Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064212
Company: TEVA PARENTERAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 50MG BASE/VIAL 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
06/23/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64212ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2001 SUPPL-5 Labeling

Label is not available on this site.

05/03/1999 SUPPL-4 Labeling

Label is not available on this site.

05/03/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/03/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/03/1999 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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