Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064097
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription AP 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
09/13/1994 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
07/25/2012 SUPPL-16 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064097s016lbl.pdf
11/18/2010 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

02/14/2007 SUPPL-14 Labeling

Label is not available on this site.

07/28/2003 SUPPL-9 Labeling

Label is not available on this site.

09/19/2000 SUPPL-7 Labeling

Label is not available on this site.

08/24/1999 SUPPL-6 Labeling

Label is not available on this site.

12/01/1998 SUPPL-5 Labeling

Label is not available on this site.

04/30/1997 SUPPL-4 Labeling

Label is not available on this site.

05/23/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/29/1996 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2012 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/064097s016lbl.pdf

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 203622 ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 063336 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription Yes AP 050629 PHARMACIA AND UPJOHN
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 064140 TEVA PHARMS USA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 200MG/100ML INJECTABLE;INJECTION Prescription No AP 064097 WEST-WARD PHARMS INT

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