Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210732
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/05/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

LEVOMILNACIPRAN HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204168 ALLERGAN
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210732 HIKMA

CAPSULE, EXTENDED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204168 ALLERGAN
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210732 HIKMA

CAPSULE, EXTENDED RELEASE;ORAL; EQ 80MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204168 ALLERGAN
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210732 HIKMA

CAPSULE, EXTENDED RELEASE;ORAL; EQ 120MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FETZIMA LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 204168 ALLERGAN
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210732 HIKMA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English