Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076310
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/29/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076310.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/04/2008 SUPPL-2 Labeling

Label is not available on this site.

01/25/2007 SUPPL-1 Labeling

Label is not available on this site.

CABERGOLINE

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 204735 INGENUS PHARMS LLC
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 077750 IVAX SUB TEVA PHARMS
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 202947 MYLAN
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 076310 PAR PHARM

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