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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210221
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/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
03/26/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

CEPHALEXIN

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210221 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065234 LUPIN
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 062703 TEVA
CEPHALEXIN CEPHALEXIN EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065336 YUNG SHIN PHARM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210221 ALKEM LABS LTD
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065234 LUPIN
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 062703 TEVA
CEPHALEXIN CEPHALEXIN EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065336 YUNG SHIN PHARM
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