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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077027
Company: TEVA

Products on ANDA 077027

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CILOSTAZOL	CILOSTAZOL	50MG	TABLET;ORAL	Prescription	AB	No	Yes
CILOSTAZOL	CILOSTAZOL	100MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077027

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/2004	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
12/18/2020	SUPPL-19	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
04/04/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/04/2016	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/09/2012	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/31/2014	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/06/2014	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/23/2014	SUPPL-7	Labeling		Label is not available on this site.
06/27/2008	SUPPL-5	Labeling		Label is not available on this site.
12/07/2006	SUPPL-3	Labeling		Label is not available on this site.
05/08/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077027

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

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