Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017962
Company: VALIDUS PHARMS
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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