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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 077646

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NDA 077646 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. Eight suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for 077646

Tradename:	BROMOCRIPTINE MESYLATE
Applicant:	Padagis Us
Ingredient:	bromocriptine mesylate
Patents:	0

Pharmacology for NDA: 077646

Medical Subject Heading (MeSH) Categories for 077646

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

Suppliers and Packaging for NDA: 077646

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	077646	ANDA	Padagis US LLC	0574-0106	0574-0106-01	100 TABLET in 1 BOTTLE, PLASTIC (0574-0106-01)
BROMOCRIPTINE MESYLATE	bromocriptine mesylate	TABLET;ORAL	077646	ANDA	Padagis US LLC	0574-0106	0574-0106-03	30 TABLET in 1 BOTTLE, PLASTIC (0574-0106-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Oct 1, 2008	TE:	AB	RLD:	No

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