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Details for New Drug Application (NDA): 074229

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NDA 074229 describes NADOLOL, which is a drug marketed by Sandoz, Ivax Sub Teva Pharms, Invagen Pharms, Teva Pharms, Mylan, Orion Corp Orion, and Impax Labs, and is included in nine NDAs. It is available from thirteen 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. Two suppliers are listed for this compound. Additional details are available on the bendroflumethiazide; nadolol profile page.

Summary for NDA: 074229

Ivax Sub Teva Pharms
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 074229

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 074229

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 074229 ANDA Teva Pharmaceuticals USA Inc 0093-4235 0093-4235-01 100 TABLET in 1 BOTTLE (0093-4235-01)
TABLET;ORAL 074229 ANDA Teva Pharmaceuticals USA Inc 0093-4236 0093-4236-01 100 TABLET in 1 BOTTLE (0093-4236-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 30, 1996TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 30, 1996TE:ABRLD:No

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