Details for New Drug Application (NDA): 210790
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NDA 210790 describes LEVOMILNACIPRAN HYDROCHLORIDE, which is a drug marketed by Amneal Pharms Co, Aurobindo Pharma Ltd, Hikma, and Prinston Inc, and is included in four NDAs. It is available from one supplier. Additional details are available on the LEVOMILNACIPRAN HYDROCHLORIDE profile page.
The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
The generic ingredient in LEVOMILNACIPRAN HYDROCHLORIDE is levomilnacipran hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levomilnacipran hydrochloride profile page.
Summary for 210790
| Tradename: | LEVOMILNACIPRAN HYDROCHLORIDE |
| Applicant: | Amneal Pharms Co |
| Ingredient: | levomilnacipran hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 210790
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 210790
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210790 | ANDA | Amneal Pharmaceuticals LLC | 65162-411 | 65162-411-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-411-03) |
| LEVOMILNACIPRAN HYDROCHLORIDE | levomilnacipran hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 210790 | ANDA | Amneal Pharmaceuticals LLC | 65162-437 | 65162-437-03 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-437-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Feb 4, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Feb 4, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 80MG BASE | ||||
| Approval Date: | Feb 4, 2019 | TE: | RLD: | No | |||||
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