Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084093
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEMBUTAL SODIUM | PENTOBARBITAL SODIUM | 50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/14/1975 | 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 |
|---|---|---|---|---|---|
| 02/06/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/20/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 03/10/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |