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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065259
Company: LUPIN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;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
05/31/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/065259s000LTR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/01/2010 SUPPL-13 Labeling

Label is not available on this site.
06/11/2008 SUPPL-6 Labeling

Label is not available on this site.
12/13/2007 SUPPL-5 Labeling

Label is not available on this site.
09/11/2007 SUPPL-4 Labeling

Label is not available on this site.
05/07/2007 SUPPL-2 Labeling

Label is not available on this site.
05/07/2007 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

CEFDINIR

FOR SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 210534 ALKEM LABS LTD
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065429 ANDA REPOSITORY
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065473 AUROBINDO PHARMA
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065259 LUPIN
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065337 SANDOZ
CEFDINIR CEFDINIR 125MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065332 TEVA PHARMS

FOR SUSPENSION;ORAL; 250MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 210534 ALKEM LABS LTD
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065429 ANDA REPOSITORY
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065473 AUROBINDO PHARMA
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065259 LUPIN
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065337 SANDOZ
CEFDINIR CEFDINIR 250MG/5ML FOR SUSPENSION;ORAL Prescription No AB 065332 TEVA PHARMS
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