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Details for New Drug Application (NDA): 076310

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NDA 076310 describes CABERGOLINE, which is a drug marketed by Apotex Corp, Par Pharm, Actavis Labs Fl Inc, Impax Labs Inc, Mylan Pharms Inc, and Ivax Sub Teva Pharms, and is included in six NDAs. It is available from six suppliers. Additional details are available on the CABERGOLINE profile page.

The generic ingredient in CABERGOLINE is cabergoline. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cabergoline profile page.

Summary for NDA: 076310

Tradename:
CABERGOLINE
Applicant:
Par Pharm
Ingredient:
cabergoline
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 076310

Ingredient-typeErgolines

Suppliers and Packaging for NDA: 076310

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CABERGOLINE
cabergoline
TABLET;ORAL 076310 ANDA Par Pharmaceutical, Inc. 49884-673 49884-673-14 8 TABLET in 1 BOTTLE (49884-673-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 29, 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.

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