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Details for New Drug Application (NDA): 090252

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NDA 090252 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Standard Chem Pharm, 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 eleven 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. Two suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.

Summary for NDA: 090252

Mylan Pharms Inc
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 090252

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 090252

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090252 ANDA Mylan Pharmaceuticals Inc. 0378-3121 0378-3121-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-3121-01)
TABLET;ORAL 090252 ANDA Mylan Pharmaceuticals Inc. 0378-3121 0378-3121-05 500 TABLET in 1 BOTTLE, PLASTIC (0378-3121-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 23, 2013TE: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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