Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206021
Company: HEC PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription AB No No
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription AB 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
01/16/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

PRASUGREL

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFIENT PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 022307 ELI LILLY AND CO
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205987 ACCORD HLTHCARE
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205913 AMNEAL PHARMS
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205888 AUROBINDO PHARMA LTD
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 206021 HEC PHARM
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205927 MYLAN PHARMS INC
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205897 PANACEA BIOTEC LTD
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205790 USPHARMA WINDLAS

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFFIENT PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 022307 ELI LILLY AND CO
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205987 ACCORD HLTHCARE
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205913 AMNEAL PHARMS
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205888 AUROBINDO PHARMA LTD
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 206021 HEC PHARM
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205927 MYLAN PHARMS INC
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205897 PANACEA BIOTEC LTD
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205790 USPHARMA WINDLAS

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