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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215043
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAMOTIDINE FAMOTIDINE 40MG/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
04/20/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

FAMOTIDINE

FOR SUSPENSION;ORAL; 40MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 201995 AKORN
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 216427 AMNEALS PHARMS
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 090440 LUPIN LTD
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 091020 NAVINTA LLC
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 201695 NOVEL LABS INC
FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION;ORAL Prescription No AB 215043 NOVITIUM PHARMA
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