Approval for synojoynt. Synojoynt is indicated for use in the treatment of pain in osteoarthritis (oa) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e. G. , acetaminophen).
| Device | SYNOJOYNT |
| Classification Name | Acid, Hyaluronic, Intraarticular |
| Generic Name | Acid, Hyaluronic, Intraarticular |
| Applicant | Teva Pharmaceuticals USA, Inc. |
| Date Received | 2017-05-15 |
| Decision Date | 2018-05-08 |
| Notice Date | 2018-05-22 |
| PMA | P170016 |
| Supplement | S |
| Product Code | MOZ |
| Docket Number | 18M-1753 |
| Advisory Committee | Orthopedic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Teva Pharmaceuticals USA, Inc. 400 Interpace Parkway parisppany, NJ 07054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P170016 | | Original Filing |
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NIH GUDID Devices