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Last Updated: March 28, 2024

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.
Summary for 210790
Pharmacology for NDA: 210790
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:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 20MG BASE
Approval Date:Feb 4, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 40MG BASE
Approval Date:Feb 4, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 80MG BASE
Approval Date:Feb 4, 2019TE:RLD:No

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