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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 077226


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NDA 077226 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 077226
Tradename:BROMOCRIPTINE MESYLATE
Applicant:Mylan
Ingredient:bromocriptine mesylate
Patents:0
Pharmacology for NDA: 077226
Medical Subject Heading (MeSH) Categories for 077226
Suppliers and Packaging for NDA: 077226
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE;ORAL 077226 ANDA Mylan Pharmaceuticals Inc. 0378-7096 0378-7096-01 100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-01)
BROMOCRIPTINE MESYLATE bromocriptine mesylate CAPSULE;ORAL 077226 ANDA Mylan Pharmaceuticals Inc. 0378-7096 0378-7096-93 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Apr 4, 2005TE:ABRLD:No

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