Details for New Drug Application (NDA): 020439

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NDA 020439 describes BETIMOL, which is a drug marketed by Thea Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the BETIMOL profile page.

The generic ingredient in BETIMOL is timolol. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the timolol profile page.

Summary for 020439

Tradename:	BETIMOL
Applicant:	Thea Pharma
Ingredient:	timolol
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020439

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 020439

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents

Suppliers and Packaging for NDA: 020439

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439	NDA	Thea Pharma Inc.	82584-001	82584-001-05	1 BOTTLE, DROPPER in 1 CARTON (82584-001-05) / 5 mL in 1 BOTTLE, DROPPER
BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439	NDA	Thea Pharma Inc.	82584-002	82584-002-05	1 BOTTLE, DROPPER in 1 CARTON (82584-002-05) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Mar 31, 1995	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Mar 31, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020439

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-001	Mar 31, 1995	⤷ Sign Up	⤷ Sign Up
Thea Pharma	BETIMOL	timolol	SOLUTION/DROPS;OPHTHALMIC	020439-002	Mar 31, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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