Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 215602
Company: AZURITY
Company: AZURITY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLEQSUVY | BACLOFEN | 25MG/5ML | SUSPENSION;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
02/04/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215602s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215602Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215602Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/04/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215602s000lbl.pdf |
FLEQSUVY
SUSPENSION;ORAL; 25MG/5ML
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BACLOFEN | BACLOFEN | 25MG/5ML | SUSPENSION;ORAL | Prescription | No | AB | 217252 | ANI PHARMS |
FLEQSUVY | BACLOFEN | 25MG/5ML | SUSPENSION;ORAL | Prescription | Yes | AB | 215602 | AZURITY |