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Generated: January 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076310

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

The generic ingredient in CABERGOLINE is cabergoline. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cabergoline profile page.
Summary for 076310
Applicant:Par Pharm
Formulation / Manufacturing:see details
Pharmacology for NDA: 076310
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)
CABERGOLINE cabergoline TABLET;ORAL 076310 ANDA A-S Medication Solutions 50090-3951 50090-3951-0 8 TABLET in 1 BOTTLE (50090-3951-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Dec 29, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Queensland Health

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