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CILOSTAZOL از شرکت APOTEX INC

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CILOSTAZOL از شرکت APOTEX INC

Abbreviated New Drug Application (ANDA): 077030

Company: APOTEX INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription

AB

No No
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
12/10/2004 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
11/16/2020 SUPPL-7 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/04/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/04/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/29/2008 SUPPL-2 Labeling

Label is not available on this site.

08/16/2007 SUPPL-1 Labeling

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 077310 CASI PHARMS INC
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077722 CHARTWELL RX
CILOSTAZOL CILOSTAZOL 50MG TABLET;ORAL Prescription No AB 077831 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

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 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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