Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 210790
Company: AMNEAL PHARMS CO
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 Discontinued None No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None 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
02/04/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210790Orig1s000ltr.pdf

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