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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Merck
Novartis
Cipla
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Healthtrust
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Citi

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074631

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NDA 074631 describes BROMOCRIPTINE MESYLATE, which is a drug marketed by Lek Pharm, Mylan, Sandoz Inc, Paddock Llc, and Zydus Pharms Usa 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 NDA: 074631

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiparkinson Agents
Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 074631

Ingredient-typeErgolines

Suppliers and Packaging for NDA: 074631

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL 074631 ANDA Sandoz Inc 0781-5325 0781-5325-01 100 TABLET in 1 BOTTLE (0781-5325-01)
BROMOCRIPTINE MESYLATE
bromocriptine mesylate
TABLET;ORAL 074631 ANDA Sandoz Inc 0781-5325 0781-5325-31 30 TABLET in 1 BOTTLE (0781-5325-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jan 13, 1998TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Colorcon
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Harvard Business School
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Dow

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