U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 215422
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LYVISPAH BACLOFEN 5MG/PACKET GRANULES;ORAL Prescription None Yes No
LYVISPAH BACLOFEN 10MG/PACKET GRANULES;ORAL Prescription None Yes No
LYVISPAH BACLOFEN 20MG/PACKET GRANULES;ORAL Prescription None Yes Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/22/2021 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215422lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215422Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215422Orig1s000TOC.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
11/22/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215422lbl.pdf
Back to Top