Details for New Drug Application (NDA): 219119
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NDA 219119 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 219119
| Tradename: | TAPENTADOL HYDROCHLORIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | tapentadol hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219119
| Mechanism of Action | Opioid Agonists |
Suppliers and Packaging for NDA: 219119
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | SOLUTION;ORAL | 219119 | ANDA | ANI Pharmaceuticals, Inc. | 70954-801 | 70954-801-10 | 1 BOTTLE in 1 CARTON (70954-801-10) / 100 mL in 1 BOTTLE |
| TAPENTADOL HYDROCHLORIDE | tapentadol hydrochloride | SOLUTION;ORAL | 219119 | ANDA | ANI Pharmaceuticals, Inc. | 70954-801 | 70954-801-20 | 1 BOTTLE in 1 CARTON (70954-801-20) / 200 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/ML | ||||
| Approval Date: | Jan 26, 2026 | TE: | RLD: | No | |||||
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