Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075287
Company: WATSON LABS
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75287ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/27/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-1 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |