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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090540
Company: AUROBINDO PHARMA LTD

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/2012/090540Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2019 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/11/2016 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
05/11/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
06/11/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
06/11/2014 SUPPL-6 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 076273 DR REDDYS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Prescription No AB 204359 GRAVITI PHARMS
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 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
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