Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005914
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PBZ | TRIPELENNAMINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
PBZ | TRIPELENNAMINE CITRATE | EQ 25MG HYDROCHLORIDE/5ML | ELIXIR;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 |
---|---|---|---|---|---|---|---|
02/19/1948 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/24/1998 | SUPPL-30 | Efficacy-New Indication |
Label is not available on this site. |