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Last Updated: February 24, 2020

DrugPatentWatch Database Preview

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, Paddock Llc, and Sandoz Inc, and is included in six NDAs. It is available from six 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. Nine suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.
Summary for 077646
Tradename:BROMOCRIPTINE MESYLATE
Applicant:Paddock Llc
Ingredient:bromocriptine mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077646
Medical Subject Heading (MeSH) Categories for 077646
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 Paddock Laboratories, LLC 0574-0106 0574-0106-01 100 TABLET in 1 BOTTLE, PLASTIC (0574-0106-01)
BROMOCRIPTINE MESYLATE bromocriptine mesylate TABLET;ORAL 077646 ANDA Paddock Laboratories, LLC 0574-0106 0574-0106-03 30 TABLET in 1 BOTTLE, PLASTIC (0574-0106-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Oct 1, 2008TE:ABRLD:No

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