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Details for New Drug Application (NDA): 073250

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NDA 073250 describes NIFEDIPINE, which is a drug marketed by Matrix 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-five 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-one suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 073250

Tradename:
NIFEDIPINE
Applicant:
Validus Pharms
Ingredient:
nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 073250

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 073250

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIFEDIPINE
nifedipine
CAPSULE;ORAL 073250 ANDA Leading Pharma, LLC 69315-211 69315-211-01 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Oct 8, 1991TE:ABRLD:No


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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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