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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077750
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/07/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/28/2023 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

12/13/2019 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

10/26/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

10/26/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

03/12/2008 SUPPL-2 Labeling

Label is not available on this site.

10/01/2007 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 218618 SKG PHARMA
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 076310 STRIDES PHARMA
CABERGOLINE CABERGOLINE 0.5MG TABLET;ORAL Prescription No AB 218109 WELDING
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