Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077022
Company: EPIC PHARMA LLC

Products on ANDA 077022

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077022

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/2004/77022ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/21/2017	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/06/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/27/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/14/2008	SUPPL-3	Labeling		Label is not available on this site.
02/14/2006	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077022

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	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

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