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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065332
Company: TEVA PHARMS

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
05/04/2007 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
06/06/2023 SUPPL-17 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
03/09/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
03/09/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
08/27/2009 SUPPL-9 Labeling

Label is not available on this site.
10/17/2008 SUPPL-8 Labeling

Label is not available on this site.
06/12/2008 SUPPL-6 Labeling

Label is not available on this site.
03/07/2008 SUPPL-5 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 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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