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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078004
Company: ACME LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/078004Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2020 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

05/20/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

06/02/2016 SUPPL-1 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 078004 ACME LABS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 203632 ALKEM LABS LTD
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 076273 DR REDDYS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 205345 HETERO LABS LTD V
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 213351 POLYGEN PHARMS
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 204359 RISING
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 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
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