Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077021
Company: CASI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOSTAZOL CILOSTAZOL 100MG 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
11/23/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/77021ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/01/2017 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/04/2016 SUPPL-13 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/10/2008 SUPPL-4 Labeling

Label is not available on this site.

CILOSTAZOL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077030 APOTEX INC
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077708 BRECKENRIDGE PHARM
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077021 CASI PHARMS INC
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077831 CHARTWELL RX
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077024 HIKMA
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077208 SLATE
CILOSTAZOL CILOSTAZOL 100MG TABLET;ORAL Prescription No AB 077027 TEVA

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