Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201046
Company: LUPIN LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;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
07/29/2013 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201046Orig1s000ltr.pdf

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANEXA RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021526 GILEAD
RANOLAZINE RANOLAZINE 500MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201046 LUPIN LTD

TABLET, EXTENDED RELEASE;ORAL; 1GM
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANEXA RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021526 GILEAD
RANOLAZINE RANOLAZINE 1GM TABLET, EXTENDED RELEASE;ORAL Prescription No AB 201046 LUPIN LTD

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