Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 209872
Company: STI PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription AB No No
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG 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
05/07/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CYCLOPHOSPHAMIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 207014 AMERIGEN PHARMS LTD
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 211608 CIPLA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription Yes AB 203856 HIKMA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 25MG CAPSULE;ORAL Prescription No AB 209872 STI PHARMA LLC

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 207014 AMERIGEN PHARMS LTD
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 211608 CIPLA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription Yes AB 203856 HIKMA
CYCLOPHOSPHAMIDE CYCLOPHOSPHAMIDE 50MG CAPSULE;ORAL Prescription No AB 209872 STI PHARMA LLC

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