Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091216
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/17/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091216Orig1s000ltr.pdf

CLOPIDOGREL BISULFATE

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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