Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063097
Company: PHARMACHEMIE BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription AP No No
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription AP No No
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL 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
05/21/1990 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
08/14/2003 SUPPL-21 Labeling

Label is not available on this site.

09/18/2002 SUPPL-19 Labeling

Label is not available on this site.

09/19/2002 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

08/25/2000 SUPPL-17 Labeling

Label is not available on this site.

08/25/2000 SUPPL-16 Labeling

Label is not available on this site.

02/15/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

07/13/1999 SUPPL-13 Labeling

Label is not available on this site.

06/07/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/03/1996 SUPPL-11 Labeling

Label is not available on this site.

01/29/1996 SUPPL-10 Labeling

Label is not available on this site.

01/29/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/29/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/29/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/29/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/26/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/31/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/31/1992 SUPPL-2 Labeling

Label is not available on this site.

DOXORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 10MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 20MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 208888 AMNEAL
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

INJECTABLE;INJECTION; 50MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 208888 AMNEAL
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 200170 MYLAN LABS LTD
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 063097 PHARMACHEMIE BV
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 50MG/VIAL INJECTABLE;INJECTION Prescription No AP 062921 WEST-WARD PHARMS INT

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