Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210574
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFIXIME CEFIXIME 400MG 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
10/09/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210574Orig1s000ltr.pdf

CEFIXIME

CAPSULE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFIXIME CEFIXIME 400MG CAPSULE;ORAL Prescription No AB 210574 ALKEM LABS LTD
SUPRAX CEFIXIME 400MG CAPSULE;ORAL Prescription Yes AB 203195 LUPIN LTD

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