Details for New Drug Application (NDA): 213479
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NDA 213479 describes LEVORPHANOL TARTRATE, which is a drug marketed by Hikma, Novitium Pharma, Specgx Llc, Sun Pharm Inds Inc, and Virtus, and is included in five NDAs. It is available from six suppliers. Additional details are available on the LEVORPHANOL TARTRATE profile page.
The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.
The generic ingredient in LEVORPHANOL TARTRATE is levorphanol tartrate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the levorphanol tartrate profile page.
Summary for 213479
| Tradename: | LEVORPHANOL TARTRATE |
| Applicant: | Novitium Pharma |
| Ingredient: | levorphanol tartrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213479
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 213479
Suppliers and Packaging for NDA: 213479
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVORPHANOL TARTRATE | levorphanol tartrate | TABLET;ORAL | 213479 | ANDA | Lannett Company, Inc. | 0527-3236 | 0527-3236-37 | 100 TABLET in 1 BOTTLE (0527-3236-37) |
| LEVORPHANOL TARTRATE | levorphanol tartrate | TABLET;ORAL | 213479 | ANDA | Lannett Company, Inc. | 0527-3237 | 0527-3237-37 | 100 TABLET in 1 BOTTLE (0527-3237-37) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 1, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG | ||||
| Approval Date: | Jan 12, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 20, 2021 | TE: | RLD: | No | |||||
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