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Details for New Drug Application (NDA): 205309

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NDA 205309 describes TIMOLOL, which is a drug marketed by Akorn, Usl Pharma, Apotex Inc, Watson Labs, Pacific Pharma, Teva, Sandoz, Fdc Ltd, Alcon Res Ltd, Hi Tech Pharma, Quantum Pharmics, Fougera, Mylan, Wockhardt, and Bausch And Lomb, and is included in thirty-nine NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TIMOLOL profile page.

The generic ingredient in TIMOLOL 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: 205309


Pharmacology for NDA: 205309

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 205309

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION/DROPS;OPHTHALMIC 205309 ANDA Akorn, Inc. 17478-365 17478-365-05 1 BOTTLE, DROPPER in 1 CARTON (17478-365-05) > 5 mL in 1 BOTTLE, DROPPER
SOLUTION/DROPS;OPHTHALMIC 205309 ANDA Akorn, Inc. 17478-366 17478-366-05 1 BOTTLE, DROPPER in 1 CARTON (17478-366-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Sep 30, 2016TE:ATRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Sep 30, 2016TE:ATRLD:No

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