Drugs@FDA: FDA Approved Drug Products

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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 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
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

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 SALES LLC
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210790 AMNEAL PHARMS CO

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 SALES LLC
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210790 AMNEAL PHARMS CO

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 SALES LLC
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210790 AMNEAL PHARMS CO

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 SALES LLC
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210790 AMNEAL PHARMS CO

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