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Serving 500+ biopharmaceutical companies globally:

Teva
Covington
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090649

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NDA 090649 describes NIFEDIPINE, which is a drug marketed by Mylan Labs Ltd, Mylan, Chase Labs Nj, Osmotica Pharm, Martec Usa Llc, Twi Pharms Inc, Osmotica Pharm Us, 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: 090649

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

Pharmacology for NDA: 090649

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 090649

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 090649 ANDA Mylan Pharmaceuticals Inc. 0378-0480 0378-0480-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0480-01)
NIFEDIPINE
nifedipine
TABLET, EXTENDED RELEASE;ORAL 090649 ANDA Mylan Pharmaceuticals Inc. 0378-0480 0378-0480-30 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0480-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jun 21, 2010TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jun 21, 2010TE:AB2RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Jun 21, 2010TE:AB2RLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
Fish and Richardson
Boehringer Ingelheim
Farmers Insurance
Cipla
Express Scripts
Chinese Patent Office
Cantor Fitzgerald
Daiichi Sankyo
Healthtrust

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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