Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077722
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOSTAZOL CILOSTAZOL 50MG 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
09/24/2012 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

CILOSTAZOL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077030 APOTEX INC
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077708 BRECKENRIDGE PHARM
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077310 CASI PHARMS INC
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077722 CHARTWELL RX
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077024 HIKMA
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077208 SLATE
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077027 TEVA

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