Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219119
Company: NOVITIUM PHARMA
Company: NOVITIUM PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAPENTADOL HYDROCHLORIDE | TAPENTADOL HYDROCHLORIDE | EQ 20MG BASE/ML | SOLUTION;ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/26/2026 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/219119Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/18/2026 | SUPPL-1 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |