Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074515
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TIMOLOL MALEATE | TIMOLOL MALEATE | EQ 0.25% BASE | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/1997 | 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 |
|---|---|---|---|---|---|
| 11/22/1999 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/06/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1999 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |