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Generated: December 11, 2018

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Details for New Drug Application (NDA): 020963

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NDA 020963 describes TIMOLOL MALEATE, which is a drug marketed by Sandoz Inc, Akorn, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Hi Tech Pharma, Pacific Pharma, Wockhardt, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in thirty-eight NDAs. It is available from thirteen suppliers. There is one patent protecting this drug. 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. Seventeen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 020963
Tradename:TIMOLOL MALEATE
Applicant:Sandoz Inc
Ingredient:timolol maleate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020963
Mechanism of ActionAdrenergic 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:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Oct 21, 1998TE:ABRLD:No
Patent:➤ Try a Free TrialPatent Expiration:Sep 26, 2019Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Oct 21, 1998TE:ABRLD:No
Patent:➤ Try a Free TrialPatent Expiration:Sep 26, 2019Product Flag?Substance Flag?Delist Request?Y

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