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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 078899

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NDA 078899 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 078899

Tradename:	BROMOCRIPTINE MESYLATE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	bromocriptine mesylate
Patents:	0

Pharmacology for NDA: 078899

Medical Subject Heading (MeSH) Categories for 078899

Antiparkinson Agents
Dopamine Agonists
Hormone Antagonists

Suppliers and Packaging for NDA: 078899

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	078899	ANDA	Zydus Lifesciences Limited	65841-654	65841-654-01	100 CAPSULE in 1 BOTTLE (65841-654-01)
BROMOCRIPTINE MESYLATE	bromocriptine mesylate	CAPSULE;ORAL	078899	ANDA	Zydus Lifesciences Limited	65841-654	65841-654-06	30 CAPSULE in 1 BOTTLE (65841-654-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jul 30, 2008	TE:	AB	RLD:	No

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