Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205581
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription AP No No
EPTIFIBATIDE EPTIFIBATIDE 75MG/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
12/08/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

EPTIFIBATIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 205557 ACCORD HLTHCARE
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 204589 AKORN
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 205581 AMNEAL PHARMS
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 206127 AUROBINDO PHARMA LTD
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 208554 BAXTER HLTHCARE CORP
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 209864 HAINAN POLY PHARM
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 203258 MYLAN LABS LTD
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 204693 SAGENT PHARMS INC
EPTIFIBATIDE EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 090854 TEVA PHARMS USA
INTEGRILIN EPTIFIBATIDE 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 020718 SCHERING

INJECTABLE;INJECTION; 75MG/100ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 205557 ACCORD HLTHCARE
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 204589 AKORN
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 205581 AMNEAL PHARMS
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 206127 AUROBINDO PHARMA LTD
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 208554 BAXTER HLTHCARE CORP
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 209864 HAINAN POLY PHARM
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 203258 MYLAN LABS LTD
EPTIFIBATIDE EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription No AP 204693 SAGENT PHARMS INC
INTEGRILIN EPTIFIBATIDE 75MG/100ML INJECTABLE;INJECTION Prescription Yes AP 020718 SCHERING

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