Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208888
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
02/17/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

DOXORUBICIN HYDROCHLORIDE

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 PHARMS CO
DOXORUBICIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE 20MG/VIAL INJECTABLE;INJECTION Prescription No AP 206062 HISUN PHARM HANGZHOU
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 PHARMS CO
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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