Details for New Drug Application (NDA): 020963

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NDA 020963 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Somerset, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from twenty-five suppliers. Additional details are available on the TIMOLOL MALEATE profile page.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 020963

Tradename:	TIMOLOL MALEATE
Applicant:	Sandoz
Ingredient:	timolol maleate
Patents:	0

Pharmacology for NDA: 020963

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 020963

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963	NDA	Sandoz Inc	61314-224	61314-224-05	5 mL in 1 BOTTLE (61314-224-05)
TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963	NDA	Sandoz Inc	61314-224	61314-224-25	2.5 mL in 1 BOTTLE (61314-224-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Oct 21, 1998	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Oct 21, 1998	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020963

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-001	Oct 21, 1998	⤷ Sign Up	⤷ Sign Up
Sandoz	TIMOLOL MALEATE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020963-002	Oct 21, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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