Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215040
Company: GALEPHAR
Company: GALEPHAR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEGUBETI | ACETYLCYSTEINE LYSINE | EQ 500MG BASE/PACKET | FOR SOLUTION;ORAL | Prescription | None | Yes | Yes |
LEGUBETI | ACETYLCYSTEINE LYSINE | EQ 2.5GM BASE/PACKET | FOR SOLUTION;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 |
---|---|---|---|---|---|---|---|
02/13/2024 | ORIG-1 | Approval | Type 2 - New Active Ingredient and Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215040s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215040Orig1s000ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/13/2024 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215040s000lbl.pdf |