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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 four 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. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the timolol maleate profile page.

Summary for NDA: 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 24208-814-25 1 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) > 5 mL in 1 BOTTLE, DISPENSING
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 020330 NDA Bausch & Lomb Incorporated 24208-816 24208-816-05 1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) > 5 mL in 1 BOTTLE, DISPENSING

Summary for product number 001

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

Summary 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 Orange Book 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;OPHTHALMIC020330-001Nov 4, 19934,195,085► subscribe
Valeant Pharms Llc
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC020330-002Nov 4, 19934,861,760► subscribe
Valeant Pharms Llc
TIMOPTIC-XE
timolol maleate
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC020330-002Nov 4, 19934,195,085► subscribe
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