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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207761


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NDA 207761 describes NADOLOL, which is a drug marketed by Alembic, Amneal Pharms Co, Aurobindo Pharma, Beximco Pharms Usa, Chartwell Rx, Heritage Pharma, Invagen Pharms, Novast Labs, Rising, Rk Pharma, Sandoz, Teva Pharms, Zydus Pharms, Impax Labs, and Mylan, and is included in sixteen NDAs. It is available from sixteen suppliers. Additional details are available on the NADOLOL profile page.

The generic ingredient in NADOLOL is bendroflumethiazide; nadolol. There are four drug master file entries for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.
Summary for 207761
Tradename:NADOLOL
Applicant:Zydus Pharms
Ingredient:nadolol
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207761
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 207761
Suppliers and Packaging for NDA: 207761
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NADOLOL nadolol TABLET;ORAL 207761 ANDA Zydus Pharmaceuticals USA Inc. 68382-732 68382-732-01 100 TABLET in 1 BOTTLE (68382-732-01)
NADOLOL nadolol TABLET;ORAL 207761 ANDA Zydus Pharmaceuticals USA Inc. 68382-732 68382-732-10 1000 TABLET in 1 BOTTLE (68382-732-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jul 28, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jul 28, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jul 28, 2017TE:ABRLD:No

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