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Serving leading biopharmaceutical companies globally:

Julphar
Cerilliant
Deloitte
Farmers Insurance
US Department of Justice
Chinese Patent Office
McKinsey
Queensland Health
Argus Health
Mallinckrodt

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075269

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NDA 075269 describes NIFEDIPINE, which is a drug marketed by Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Intergel Pharm, Teva, Validus Pharms, Martec Usa Llc, Mylan, Mylan Labs Ltd, Novast Labs Ltd, Osmotica Pharm Us, Par Pharm, Twi Pharms Inc, and Valeant Pharms North, and is included in twenty-two NDAs. It is available from forty-seven 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 075269

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075269

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 075269

Suppliers and Packaging for NDA: 075269

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075269 ANDA TEVA PHARMACEUTICALS USA 0093-2057 0093-2057-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0093-2057-01)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075269 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-209 43353-209-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43353-209-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Dec 4, 2000TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Dec 4, 2000TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Novartis
Covington
Julphar
Fuji
Dow
Chinese Patent Office
Daiichi Sankyo
Deloitte
Medtronic

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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