Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076274
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription AB No No
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG 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
03/04/2014 ORIG-2 Approval

Label is not available on this site.

05/17/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076274Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/03/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/13/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

CLOPIDOGREL BISULFATE

TABLET;ORAL; EQ 75MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202925 ACCORD HLTHCARE
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 078004 ACME LABS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 203751 AMNEAL PHARMS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076274 APOTEX INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090540 AUROBINDO PHARMA LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202266 CELLTRION
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 204359 CSPC OUYI
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076273 DR REDDYS LABS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 202928 MACLEODS PHARMS LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 206376 PRINSTON INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 204165 SCIEGEN PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090494 SUN PHARM
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 076999 TEVA
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 090844 TORRENT PHARMS LTD
PLAVIX CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription Yes AB 020839 SANOFI AVENTIS US

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 202925 ACCORD HLTHCARE
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 090625 ANI PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091216 ANI PHARMS INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 076274 APOTEX INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 202266 CELLTRION
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 091023 DR REDDYS LABS LTD
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 206376 PRINSTON INC
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription No AB 204165 SCIEGEN PHARMS INC
PLAVIX CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Prescription Yes AB 020839 SANOFI AVENTIS US

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