Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065330
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/06/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/14/2009 SUPPL-3 Labeling

Label is not available on this site.

12/15/2008 SUPPL-1 Labeling

Label is not available on this site.

CEFDINIR

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065434 AUROBINDO PHARMA
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065264 LUPIN
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065418 ORCHID HLTHCARE
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065330 SANDOZ
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065368 TEVA PHARMS

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