Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086826
Company: FOREST LABS
Company: FOREST LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELIXOPHYLLIN SR | THEOPHYLLINE | 125MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ELIXOPHYLLIN SR | THEOPHYLLINE | 250MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 02/06/1998 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/27/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |