Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017962
Company: VALIDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PARLODEL BROMOCRIPTINE MESYLATE EQ 2.5MG BASE TABLET;ORAL Prescription AB Yes No
PARLODEL BROMOCRIPTINE MESYLATE EQ 5MG BASE CAPSULE;ORAL Prescription AB Yes No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/12/2021 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/017962s083lbl.pdf
12/13/2019 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017962s081lbl.pdf
01/05/2012 SUPPL-68 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
01/05/2012 SUPPL-65 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/017962s065s068lbl.pdf
11/09/2005 SUPPL-64 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf
11/09/2005 SUPPL-63 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/017962s063,064lbl.pdf

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