Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076061
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PERGOLIDE MESYLATE PERGOLIDE MESYLATE EQ 0.05MG BASE TABLET;ORAL Discontinued None No No
PERGOLIDE MESYLATE PERGOLIDE MESYLATE EQ 0.25MG BASE TABLET;ORAL Discontinued None No No
PERGOLIDE MESYLATE PERGOLIDE MESYLATE EQ 1MG BASE TABLET;ORAL Discontinued None 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
11/27/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076061.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2004 SUPPL-2 Labeling

Label is not available on this site.

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