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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020330

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NDA 020330 describes TIMOPTIC-XE, which is a drug marketed by Valeant Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the TIMOPTIC-XE profile page.

The generic ingredient in TIMOPTIC-XE is timolol maleate. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 020330
Tradename:TIMOPTIC-XE
Applicant:Valeant Pharms Llc
Ingredient:timolol maleate
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020330
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 020330
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330 NDA Bausch & Lomb Incorporated 24208-814 N 24208-814-25
TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330 NDA Bausch & Lomb Incorporated 24208-816 N 24208-816-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Nov 4, 1993TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Nov 4, 1993TE:ABRLD:Yes

Expired US Patents for NDA 020330

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-002 Nov 4, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Llc TIMOPTIC-XE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330-001 Nov 4, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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