Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215422
Company: AMNEAL
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 |