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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076070

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NDA 076070 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 076070

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

Pharmacology for NDA: 076070

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 076070

Suppliers and Packaging for NDA: 076070

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 076070 ANDA State of Florida DOH Central Pharmacy 53808-0500 53808-0500-1 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (53808-0500-1)
NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 076070 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-258 55700-258-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (55700-258-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Aug 16, 2002TE:AB1RLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
Deloitte
Julphar
Johnson and Johnson
Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
US Army
Colorcon
Teva

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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