U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 213378
Company: ALKERMES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYBALVI OLANZAPINE; SAMIDORPHAN L-MALATE 5MG;EQ 10MG BASE TABLET;ORAL Prescription None Yes Yes
LYBALVI OLANZAPINE; SAMIDORPHAN L-MALATE 10MG;EQ 10MG BASE TABLET;ORAL Prescription None Yes No
LYBALVI OLANZAPINE; SAMIDORPHAN L-MALATE 15MG;EQ 10MG BASE TABLET;ORAL Prescription None Yes No
LYBALVI OLANZAPINE; SAMIDORPHAN L-MALATE 20MG;EQ 10MG BASE TABLET;ORAL Prescription None Yes 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
05/28/2021 ORIG-2 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213378Orig1s000, Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213378Orig1Orig2s000TOC.cfm
05/28/2021 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213378Orig1s000, Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213378Orig1Orig2s000TOC.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/28/2021 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf
05/28/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf
Back to Top