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Details for New Drug Application (NDA): 201189

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NDA 201189 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-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: 201189

Tradename:
REPAGLINIDE
Applicant:
Paddock Llc
Ingredient:
repaglinide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 201189

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 201189

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE
repaglinide
TABLET;ORAL 201189 ANDA Paddock Laboratories, LLC 0574-0240 0574-0240-01 100 TABLET in 1 BOTTLE (0574-0240-01)
REPAGLINIDE
repaglinide
TABLET;ORAL 201189 ANDA Paddock Laboratories, LLC 0574-0240 0574-0240-05 500 TABLET in 1 BOTTLE (0574-0240-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 17, 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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