Details for New Drug Application (NDA): 010533
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NDA 010533 describes PBZ-SR, which is a drug marketed by Novartis and is included in one NDA. Additional details are available on the PBZ-SR profile page.
The generic ingredient in PBZ-SR is tripelennamine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the tripelennamine hydrochloride profile page.
The generic ingredient in PBZ-SR is tripelennamine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the tripelennamine hydrochloride profile page.
Summary for 010533
| Tradename: | PBZ-SR |
| Applicant: | Novartis |
| Ingredient: | tripelennamine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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