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Details for New Drug Application (NDA): 018086

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NDA 018086 describes TIMOPTIC, which is a drug marketed by Aton and Valeant Pharms Llc and is included in three NDAs. It is available from one supplier. Additional details are available on the TIMOPTIC profile page.

The generic ingredient in TIMOPTIC 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: 018086

Tradename:
TIMOPTIC
Applicant:
Aton
Ingredient:
timolol maleate
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018086

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018086

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC 018086 NDA Aton Pharma, Inc. 25010-812 25010-812-56 1 BOTTLE, DISPENSING in 1 CARTON (25010-812-56) > 5 mL in 1 BOTTLE, DISPENSING
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC 018086 NDA Aton Pharma, Inc. 25010-813 25010-813-16 1 BOTTLE, DISPENSING in 1 CARTON (25010-813-16) > 10 mL in 1 BOTTLE, DISPENSING

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Approved Prior to Jan 1, 1982TE:AT1RLD:Yes

Expired Orange Book Patents for NDA: 018086

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Aton
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC018086-001Approved Prior to Jan 1, 19823,655,663► subscribe
Aton
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC018086-002Approved Prior to Jan 1, 19824,195,085► subscribe
Aton
TIMOPTIC
timolol maleate
SOLUTION/DROPS;OPHTHALMIC018086-002Approved Prior to Jan 1, 19823,655,663► subscribe
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