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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205927
Company: MYLAN
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
07/12/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205927Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/24/2020 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205927Orig1s000lbl.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 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
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 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
PRASUGREL PRASUGREL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Prescription No AB 205897 PANACEA
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