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Last Updated: March 29, 2024

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 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. Eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 074631
Medical Subject Heading (MeSH) Categories for 074631
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:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jan 13, 1998TE:ABRLD:No

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