Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008306
Company: ANI PHARMS
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PHENERGAN VC W/ CODEINE | CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |
| PHENERGAN W/ CODEINE | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008306Orig1s036lbl.pdf | |
| 12/15/2023 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008306s035lbl.pdf | |
| 12/15/2023 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008306s035lbl.pdf | |
| 06/28/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf | |
| 08/29/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s033lbl.pdf | |
| 01/13/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf | |
| 01/13/2017 | SUPPL-32 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf | |
| 05/09/2013 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf | |
| 11/26/2008 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf |