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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074746
Company: PACIFIC PHARMA

Products on ANDA 074746

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074746

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/25/1997	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
04/03/2020	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/06/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/08/2005	SUPPL-10	Labeling		Label is not available on this site.
07/14/2003	SUPPL-8	Labeling		Label is not available on this site.
11/15/2002	SUPPL-7	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/03/2002	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
01/08/2002	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
08/15/2001	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
12/08/2000	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
03/29/2000	SUPPL-2	Labeling		Label is not available on this site.
12/16/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074746

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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