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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 207556


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NDA 207556 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Somerset, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from twenty-four suppliers. 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. Twenty-eight suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 207556
Tradename:TIMOLOL MALEATE
Applicant:Rising
Ingredient:timolol maleate
Patents:0
Pharmacology for NDA: 207556
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 207556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate TABLET;ORAL 207556 ANDA Athem LLC 73152-029 73152-029-01 100 TABLET in 1 BOTTLE (73152-029-01)
TIMOLOL MALEATE timolol maleate TABLET;ORAL 207556 ANDA Athem LLC 73152-030 73152-030-01 100 TABLET in 1 BOTTLE (73152-030-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 2, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 2, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 2, 2019TE:ABRLD:No

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