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Details for New Drug Application (NDA): 022386

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NDA 022386 describes PRANDIMET, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from one supplier. Additional details are available on the PRANDIMET profile page.

The generic ingredient in PRANDIMET is metformin hydrochloride; repaglinide. There are forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for NDA: 022386

Tradename:
PRANDIMET
Applicant:
Novo Nordisk Inc
Ingredient:
metformin hydrochloride; repaglinide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 022386

Ingredient-typeBiguanides
Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 022386

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRANDIMET
metformin hydrochloride; repaglinide
TABLET;ORAL 022386 NDA Novo Nordisk 0169-0092 0169-0092-01 1 BOTTLE, PLASTIC in 1 CARTON (0169-0092-01) > 100 TABLET in 1 BOTTLE, PLASTIC
PRANDIMET
metformin hydrochloride; repaglinide
TABLET;ORAL 022386 NDA Novo Nordisk 0169-0092 0169-0092-21 1 BOTTLE, PLASTIC in 1 CARTON (0169-0092-21) > 20 TABLET in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;1MG
Approval Date:Jun 23, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;2MG
Approval Date:Jun 23, 2008TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 022386

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
PRANDIMET
metformin hydrochloride; repaglinide
TABLET;ORAL022386-001Jun 23, 2008RE37035► subscribe
Novo Nordisk Inc
PRANDIMET
metformin hydrochloride; repaglinide
TABLET;ORAL022386-002Jun 23, 2008RE37035► subscribe
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