Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076061
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| 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. |