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HYDROCHLORIDE | 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |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PROMETHAZINE HYDROCHLORIDE | 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SYRUP;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/21/1952 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
| 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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/008306Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/008306Orig1s036ltr.pdf | |
| 12/15/2023 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/008306s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/008306Orig1s035ltr.pdf | |
| 06/28/2018 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/008306s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/008306Orig1s034ltr.pdf | |
| 08/29/2017 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s033ltr.pdf | |
| 01/13/2017 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008306s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008306Orig1s032ltr.pdf | |
| 05/09/2013 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/008306s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/008306Orig1s031ltr.pdf | |
| 11/26/2008 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/008306s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/008306s030ltr.pdf | |
| 02/23/2001 | SUPPL-29 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/008306_S029_PHENERGA-CODEINE_AP.pdf |
| 06/23/2000 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1998 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/30/1988 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/04/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/29/1985 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1987 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1986 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1984 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/02/1984 | SUPPL-11 | Efficacy |
Label is not available on this site. |
||
| 04/02/1984 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| 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 |