Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022556
Company: AYTU
Company: AYTU
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KARBINAL ER | CARBINOXAMINE MALEATE | 4MG/5ML | SUSPENSION, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/10/2026 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022556Orig1s015lbl.pdf | |
| 03/25/2021 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022556s006lbl.pdf | |
| 03/28/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022556s000lbl.pdf |