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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, Sandoz Inc, Paddock Llc, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the bromocriptine mesylate profile page.

Summary for NDA: 077226

Pharmacology for NDA: 077226


Suppliers and Packaging for NDA: 077226

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
CAPSULE;ORAL 077226 ANDA Mylan Pharmaceuticals Inc. 0378-7096 0378-7096-93 30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Apr 4, 2005TE:ABRLD:Yes

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.