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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Julphar
Cipla
Queensland Health
Fuji
Farmers Insurance
Colorcon
QuintilesIMS
Deloitte

Generated: July 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203126

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NDA 203126 describes NIFEDIPINE, which is a drug marketed by Mylan Labs Ltd, Mylan, Chase Labs Nj, Osmotica Pharm Us, Martec Usa Llc, Twi Pharms Inc, Heritage Pharma, Validus Pharms, Teva, Actavis Elizabeth, Valeant Pharms North, Intergel Pharm, Novast Labs Ltd, and Par Pharm, and is included in twenty-two NDAs. It is available from forty-six suppliers. Additional details are available on the NIFEDIPINE profile page.

The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 203126

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203126

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 203126

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 203126 ANDA Par Pharmaceutical, Inc. 10370-390 10370-390-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-390-01)
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 203126 ANDA Par Pharmaceutical, Inc. 10370-390 10370-390-30 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-390-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 3, 2014TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 3, 2014TE:AB2RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Apr 3, 2014TE:AB2RLD:No


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Serving 500+ biopharmaceutical companies globally:

Colorcon
McKinsey
Daiichi Sankyo
Healthtrust
Accenture
Harvard Business School
Teva
Johnson and Johnson
Chubb
McKesson

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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