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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210721
Company: APOTEX

Products on ANDA 210721

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	AB1	No	No
CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE;ORAL	Prescription	AB1	No	No
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210721

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210721

CYCLOSPORINE

CAPSULE;ORAL; 25MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	210721	APOTEX
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065044	DR REDDYS LABS SA
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065110	IVAX SUB TEVA PHARMS
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065017	SANDOZ
CYCLOSPORINE	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	216046	STRIDES PHARMA
GENGRAF	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	No	AB1	065003	ABBVIE
NEORAL	CYCLOSPORINE	25MG	CAPSULE;ORAL	Prescription	Yes	AB1	050715	NOVARTIS

CAPSULE;ORAL; 50MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE;ORAL	Prescription	No	AB1	210721	APOTEX
CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE;ORAL	Prescription	No	AB1	065110	IVAX SUB TEVA PHARMS
CYCLOSPORINE	CYCLOSPORINE	50MG	CAPSULE;ORAL	Prescription	No	AB1	216046	STRIDES PHARMA

CAPSULE;ORAL; 100MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	210721	APOTEX
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065044	DR REDDYS LABS SA
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065110	IVAX SUB TEVA PHARMS
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065017	SANDOZ
CYCLOSPORINE	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	216046	STRIDES PHARMA
GENGRAF	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	No	AB1	065003	ABBVIE
NEORAL	CYCLOSPORINE	100MG	CAPSULE;ORAL	Prescription	Yes	AB1	050715	NOVARTIS

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