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Serving leading biopharmaceutical companies globally:

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Generated: December 11, 2017

DrugPatentWatch Database Preview

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, Sandoz, Teva, Usl Pharma, and Watson Labs, and is included in thirty-eight NDAs. It is available from sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 204936

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
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

Summary 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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