Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063336
Company: PHARMACHEMIE BV
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
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
02/28/1995 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
09/19/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

08/25/2000 SUPPL-6 Labeling

Label is not available on this site.

08/25/2000 SUPPL-5 Labeling

Label is not available on this site.

03/30/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-3 Labeling

Label is not available on this site.

04/03/1996 SUPPL-2 Labeling

Label is not available on this site.

11/01/1995 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

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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