Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083149
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PBZ | TRIPELENNAMINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 09/06/1973 | 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 |
|---|---|---|---|---|---|
| 07/20/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1997 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1983 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |