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Last Updated: December 31, 2025

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, Zydus Pharms Usa Inc, Aurobindo Pharma Usa, Padagis Us, and Sandoz, and is included in six NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for 074631

Tradename:	BROMOCRIPTINE MESYLATE
Applicant:	Sandoz
Ingredient:	bromocriptine mesylate
Patents:	0

Pharmacology for NDA: 074631

Medical Subject Heading (MeSH) Categories for 074631

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Jan 13, 1998	TE:	AB	RLD:	No

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