Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207556
Company: ELYSIUM

Products on ANDA 207556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET;ORAL	Prescription	AB	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET;ORAL	Prescription	AB	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207556

TIMOLOL MALEATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	207556	ELYSIUM
TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET;ORAL	Prescription	No	AB	072668	MYLAN

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	207556	ELYSIUM
TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	072668	MYLAN

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	207556	ELYSIUM
TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET;ORAL	Prescription	No	AB	072668	MYLAN