Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065429
Company: ORCHID HLTHCARE
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
07/18/2007 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
07/21/2009 SUPPL-3 Labeling

Label is not available on this site.

02/06/2008 SUPPL-1 Labeling

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 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 065429 ORCHID HLTHCARE
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 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 065429 ORCHID HLTHCARE
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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