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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203820

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NDA 203820 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Boscogen, Aurobindo Pharma Ltd, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Paddock Llc, and Lupin Ltd, and is included in eight NDAs. It is available from thirteen suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for NDA: 203820

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 203820

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 203820

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE
repaglinide
TABLET;ORAL 203820 ANDA Citron Pharma LLC 57237-157 57237-157-01 100 TABLET in 1 BOTTLE (57237-157-01)
REPAGLINIDE
repaglinide
TABLET;ORAL 203820 ANDA Citron Pharma LLC 57237-157 57237-157-05 500 TABLET in 1 BOTTLE (57237-157-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 22, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jan 22, 2014TE:ABRLD:No


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