Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077665
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 75MG BASE TABLET;ORAL Discontinued None No No
CLOPIDOGREL BISULFATE CLOPIDOGREL BISULFATE EQ 300MG BASE TABLET;ORAL Discontinued None 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/2012/077665Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/01/2019 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/26/2019 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/26/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/26/2019 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

06/26/2019 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/11/2019 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-3 Labeling-Medication Guide

Label is not available on this site.

02/29/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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