Details for New Drug Application (NDA): 078913
NDA 078913 describes PROTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Hikma, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from two suppliers. Additional details are available on the PROTRIPTYLINE HYDROCHLORIDE profile page.
The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.
Summary for 078913
| Tradename: | PROTRIPTYLINE HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | protriptyline hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 078913
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 16, 2008 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 16, 2008 | TE: | RLD: | No | |||||
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