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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077226

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NDA 077226 describes BROMOCRIPTINE MESYLATE, which is a drug marketed by Lek Pharm, Mylan, Zydus Pharms Usa Inc, Paddock Llc, and Sandoz Inc, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the BROMOCRIPTINE MESYLATE profile page.

The generic ingredient in BROMOCRIPTINE MESYLATE is bromocriptine mesylate. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 077226
Tradename:BROMOCRIPTINE MESYLATE
Applicant:Mylan
Ingredient:bromocriptine mesylate
Patents:0
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Pharmacology for NDA: 077226
Ingredient-typeErgolines
Medical Subject Heading (MeSH) Categories for 077226
Suppliers and Packaging for NDA: 077226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE;ORAL 077226 ANDA Mylan Pharmaceuticals Inc. 0378-7096 N 0378-7096-93
BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE;ORAL 077226 ANDA Mylan Pharmaceuticals Inc. 0378-7096 N 0378-7096-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Apr 4, 2005TE:ABRLD:No

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