Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010124
Company: LANNETT
Company: LANNETT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SERPALAN | RESERPINE | 0.1MG | TABLET;ORAL | Discontinued | None | No | No |
| SERPALAN | RESERPINE | 0.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/12/1955 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/15/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/08/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/28/1977 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |