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Dow
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076962

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NDA 076962 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 ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 076962
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: 076962
Ingredient-typeErgolines
Medical Subject Heading (MeSH) Categories for 076962
Suppliers and Packaging for NDA: 076962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMOCRIPTINE MESYLATE bromocriptine mesylate TABLET;ORAL 076962 ANDA KAISER FOUNDATION HOSPITALS 0179-0165 N 0179-0165-70
BROMOCRIPTINE MESYLATE bromocriptine mesylate TABLET;ORAL 076962 ANDA Mylan Pharmaceuticals Inc. 0378-2042 N 0378-2042-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Sep 24, 2004TE:ABRLD:No

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