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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074261
Company: SANDOZ

Products on ANDA 074261

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074261

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/1995	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
11/22/2022	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
11/22/2022	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
04/08/2005	SUPPL-17	Labeling		Label is not available on this site.
05/21/2004	SUPPL-16	Labeling		Label is not available on this site.
03/21/2003	SUPPL-14	Labeling		Label is not available on this site.
10/01/2002	SUPPL-13	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/28/2002	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/05/2002	SUPPL-11	Labeling		Label is not available on this site.
04/07/2000	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/28/2000	SUPPL-9	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/27/1999	SUPPL-8	Labeling		Label is not available on this site.
03/23/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/07/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
07/28/1999	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/20/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/27/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/27/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/04/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074261

TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.25% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074778	BAUSCH AND LOMB
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	077259	FDC LTD
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	078771	MANKIND PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	217343	MICRO LABS
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074746	PACIFIC PHARMA
TIMOLOL MALEATE	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	074261	SANDOZ
TIMOPTIC	TIMOLOL MALEATE	EQ 0.25% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	018086	BAUSCH AND LOMB INC

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