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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210771
Company: PRINSTON INC

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
03/20/2023 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210771Orig1s000TA_ltr.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 ABBVIE
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 20MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210771 PRINSTON INC

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 ABBVIE
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 40MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210771 PRINSTON INC

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 ABBVIE
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 80MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210771 PRINSTON INC

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 ABBVIE
LEVOMILNACIPRAN HYDROCHLORIDE LEVOMILNACIPRAN HYDROCHLORIDE EQ 120MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 210771 PRINSTON INC
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