Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 005213
Company: GENUS
Company: GENUS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG;5MG | TABLET;ORAL | Prescription | AA | Yes | No |
| HYCODAN | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE | 1.5MG/5ML;5MG/5ML | SYRUP;ORAL | Prescription | AA | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/005213Orig1s048lbl.pdf | |
| 12/15/2023 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/005213s046lbl.pdf | |
| 09/27/2021 | SUPPL-44 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/005213Orig1s044lbl.pdf | |
| 06/28/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf | |
| 06/28/2018 | SUPPL-39 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/005213s039lbl.pdf | |
| 01/13/2017 | SUPPL-38 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf | |
| 01/13/2017 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005213s038lbl.pdf | |
| 01/26/2009 | SUPPL-37 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/005213s037lbl.pdf |