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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205897
Company: PANACEA
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
10/16/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205897Orig1s000ltr.pdf

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 COSETTE
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 205888 AUROBINDO PHARMA
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
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Prescription No AB 205897 PANACEA

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 COSETTE
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 205888 AUROBINDO PHARMA
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
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205897 PANACEA
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