Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075595
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PEMOLINE | PEMOLINE | 18.75MG | TABLET;ORAL | Discontinued | None | No | No |
PEMOLINE | PEMOLINE | 37.5MG | TABLET;ORAL | Discontinued | None | No | No |
PEMOLINE | PEMOLINE | 75MG | 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 |
---|---|---|---|---|---|---|---|
02/28/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75595ltr.pdf |