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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209811
Company: DEVA HOLDING AS

Products on ANDA 209811

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209811

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/21/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209811

CYCLOSPORINE

EMULSION;OPHTHALMIC; 0.05%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211909	AMNEAL
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	209811	DEVA HOLDING AS
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	205894	MYLAN
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	211943	SAPTALIS PHARMS
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	203880	TEVA PHARMS USA INC
CYCLOSPORINE	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	No	AB	209064	TWI PHARMS
RESTASIS	CYCLOSPORINE	0.05%	EMULSION;OPHTHALMIC	Prescription	Yes	AB	050790	ABBVIE

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