Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072668
Company: MYLAN

Products on ANDA 072668

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	20MG	TABLET;ORAL	Discontinued	None	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	5MG	TABLET;ORAL	Discontinued	None	No	No
TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072668

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/1990	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2003	SUPPL-12	Labeling		Label is not available on this site.
06/06/2003	SUPPL-11	Labeling		Label is not available on this site.
01/17/2001	SUPPL-10	Labeling		Label is not available on this site.
10/01/1999	SUPPL-9	Labeling		Label is not available on this site.
04/23/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
09/06/1995	SUPPL-6	Labeling		Label is not available on this site.
11/16/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/14/1993	SUPPL-3	Labeling		Label is not available on this site.
07/10/1992	SUPPL-2	Labeling		Label is not available on this site.
07/10/1991	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072668

TIMOLOL MALEATE

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	072668	MYLAN
TIMOLOL MALEATE	TIMOLOL MALEATE	10MG	TABLET;ORAL	Prescription	No	AB	207556	RISING