Details for New Drug Application (NDA): 205057
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NDA 205057 describes TAPENTADOL HYDROCHLORIDE, which is a drug marketed by Novitium Pharma, Epic Pharma Llc, and Hikma, and is included in three NDAs. It is available from two suppliers. Additional details are available on the TAPENTADOL HYDROCHLORIDE profile page.
The generic ingredient in TAPENTADOL HYDROCHLORIDE is tapentadol hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
The generic ingredient in TAPENTADOL HYDROCHLORIDE is tapentadol hydrochloride. There are five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tapentadol hydrochloride profile page.
Summary for 205057
| Tradename: | TAPENTADOL HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Feb 10, 2026 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Feb 10, 2026 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Feb 10, 2026 | TE: | RLD: | No | |||||
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