Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077030
Company: APOTEX INC

Products on ANDA 077030

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077030

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.

Therapeutic Equivalents for ANDA 077030

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	077722	CHARTWELL RX
CILOSTAZOL	CILOSTAZOL	50MG	TABLET;ORAL	Prescription	No	AB	077831	CHARTWELL RX
CILOSTAZOL	CILOSTAZOL	50MG	TABLET;ORAL	Prescription	No	AB	077022	EPIC PHARMA LLC
CILOSTAZOL	CILOSTAZOL	50MG	TABLET;ORAL	Prescription	No	AB	077208	SLATE RUN PHARMA
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	077831	CHARTWELL RX
CILOSTAZOL	CILOSTAZOL	100MG	TABLET;ORAL	Prescription	No	AB	077022	EPIC PHARMA LLC
CILOSTAZOL	CILOSTAZOL	100MG	TABLET;ORAL	Prescription	No	AB	077208	SLATE RUN PHARMA
CILOSTAZOL	CILOSTAZOL	100MG	TABLET;ORAL	Prescription	No	AB	077027	TEVA