Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202588
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;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
03/04/2014 ORIG-1 Approval

Label is not available on this site.

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN

CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL; 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL Prescription No AB 202588 SANDOZ INC

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