Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PBZ-SR | TRIPELENNAMINE HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
PBZ-SR | TRIPELENNAMINE HYDROCHLORIDE | 50MG | TABLET, 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 |
---|---|---|---|---|---|---|---|
07/05/1956 | 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 |
---|---|---|---|---|---|
04/23/1999 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/19/1992 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/07/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
03/20/1998 | SUPPL-24 | Efficacy-New Indication |
Label is not available on this site. |
||
12/07/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |