Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050704
Company: GALEN (UK)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DAUNOXOME DAUNORUBICIN CITRATE EQ 2MG BASE/ML INJECTABLE, LIPOSOMAL;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
04/08/1996 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/10/2002 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/23/2000 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/28/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/28/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50704s8ltr.pdf
03/23/1999 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1998 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/24/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/11/1997 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/11/1996 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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