Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205894
Company: MYLAN

Products on ANDA 205894

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 205894

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/02/2022	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205894Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/205894Orig1s000.pdf

Therapeutic Equivalents for ANDA 205894

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