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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210220
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFDINIR CEFDINIR 300MG CAPSULE;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
02/19/2021 ORIG-1 Approval STANDARD

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 210220 ALKEM LABS LTD
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065418 ANDA REPOSITORY
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 065330 SANDOZ
CEFDINIR CEFDINIR 300MG CAPSULE;ORAL Prescription No AB 065368 TEVA PHARMS
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