Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063277
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML 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
10/26/1995 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
11/05/2014 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

05/14/2007 SUPPL-14 Labeling

Label is not available on this site.

12/05/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

07/20/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/20/2000 SUPPL-9 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/20/2000 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/28/1999 SUPPL-7 Labeling

Label is not available on this site.

11/29/1996 SUPPL-6 Labeling

Label is not available on this site.

01/10/1997 SUPPL-5 Labeling

Label is not available on this site.

01/10/1997 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

01/10/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/10/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/10/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 203622 ACTAVIS INC
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 063277 FRESENIUS KABI USA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209825 GLAND PHARMA LTD
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 063336 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 050629 PHARMACIA AND UPJOHN
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 091495 SAGENT PHARMS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 091418 SUN PHARM INDS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 064140 TEVA PHARMS USA
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 062975 WEST-WARD PHARMS INT

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