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Details for New Drug Application (NDA): 091517

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NDA 091517 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: 091517

Standard Chem Pharm
Therapeutic Class:Blood Glucose Regulators

Pharmacology for NDA: 091517

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 091517

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 091517 ANDA Breckenridge Pharmaceutical, Inc. 51991-853 51991-853-01 100 TABLET in 1 BOTTLE (51991-853-01)
TABLET;ORAL 091517 ANDA Breckenridge Pharmaceutical, Inc. 51991-854 51991-854-01 100 TABLET in 1 BOTTLE (51991-854-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Apr 24, 2015TE:ABRLD:No

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