Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074890
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIMETIDINE CIMETIDINE 200MG TABLET;ORAL Prescription AB No No
CIMETIDINE CIMETIDINE 300MG TABLET;ORAL Prescription AB No No
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription AB No No
CIMETIDINE CIMETIDINE 800MG 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
12/18/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-890_Cimetidine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74890ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-890_Cimetidine.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74-890_Cimetidine_prntlbl.pdf

CIMETIDINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIMETIDINE CIMETIDINE 200MG TABLET;ORAL Prescription No AB 074890 HIKMA
CIMETIDINE CIMETIDINE 200MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 200MG TABLET;ORAL Prescription No AB 074151 TEVA

TABLET;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIMETIDINE CIMETIDINE 300MG TABLET;ORAL Prescription No AB 074890 HIKMA
CIMETIDINE CIMETIDINE 300MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 300MG TABLET;ORAL Prescription No AB 074151 TEVA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription No AB 074890 HIKMA
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 400MG TABLET;ORAL Prescription No AB 074151 TEVA

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074890 HIKMA
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074246 MYLAN
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074566 PLIVA
CIMETIDINE CIMETIDINE 800MG TABLET;ORAL Prescription No AB 074463 TEVA

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