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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Fuji
Johnson and Johnson
QuintilesIMS
Daiichi Sankyo
Cipla
Farmers Insurance
Citi
Moodys
Colorcon

Generated: August 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020741

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NDA 020741 describes PRANDIN, which is a drug marketed by Gemini Labs Llc and is included in one NDA. It is available from five suppliers. Additional details are available on the PRANDIN profile page.

The generic ingredient in PRANDIN is repaglinide. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the repaglinide profile page.

Summary for NDA: 020741

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

Pharmacology for NDA: 020741

Mechanism of ActionPotassium Channel Antagonists

Suppliers and Packaging for NDA: 020741

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PRANDIN
repaglinide
TABLET;ORAL 020741 NDA Novo Nordisk 0169-0081 0169-0081-80 12 TABLET in 1 BOTTLE, PLASTIC (0169-0081-80)
PRANDIN
repaglinide
TABLET;ORAL 020741 NDA Novo Nordisk 0169-0081 0169-0081-81 100 TABLET in 1 BOTTLE, PLASTIC (0169-0081-81)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 22, 1997TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 22, 1997TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Dec 22, 1997TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 020741

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-002Dec 22, 1997► Subscribe► Subscribe
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-003Dec 22, 1997► Subscribe► Subscribe
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-001Dec 22, 1997► Subscribe► Subscribe
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-003Dec 22, 1997► Subscribe► Subscribe
Gemini Labs Llc
PRANDIN
repaglinide
TABLET;ORAL020741-002Dec 22, 1997► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Federal Trade Commission
Argus Health
Dow
Moodys
Queensland Health
Farmers Insurance
Accenture
Harvard Business School

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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