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Generated: November 15, 2018

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Details for New Drug Application (NDA): 204936

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NDA 204936 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 204936
Tradename:TIMOLOL MALEATE
Applicant:Apotex Inc
Ingredient:timolol maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204936
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 204936
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 204936 ANDA Apotex Corp 60505-1005 60505-1005-1 1 BOTTLE, DROPPER in 1 CARTON (60505-1005-1) > 5 mL in 1 BOTTLE, DROPPER
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 204936 ANDA Apotex Corp 60505-1005 60505-1005-4 1 BOTTLE, DROPPER in 1 CARTON (60505-1005-4) > 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Apr 17, 2015TE:AT2RLD:No

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