Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063165
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADRIAMYCIN PFS DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Discontinued None No No
ADRIAMYCIN PFS DOXORUBICIN HYDROCHLORIDE 200MG/100ML 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
01/30/1991 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
12/05/2011 SUPPL-12 Labeling-Patient Package Insert

Label is not available on this site.

01/05/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

08/16/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/24/1999 SUPPL-9 Labeling

Label is not available on this site.

10/12/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/19/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/09/1993 SUPPL-6 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s006_adriamycin_toc.cfm
07/09/1993 SUPPL-5 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s005_adriamycin_toc.cfm
06/01/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/09/1993 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/063165s003_adriamycin_toc.cfm
06/02/1995 SUPPL-2 Labeling

Label is not available on this site.

06/02/1995 SUPPL-1 Labeling

Label is not available on this site.

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