Drugs@FDA: FDA-Approved Drugs
Company: GENUS LIFESCIENCES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION;ORAL | Prescription | AA | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/21/1981 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-56 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-43 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 01/29/2018 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/2015 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/25/2008 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/07/2008 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 07/19/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 08/17/1993 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/02/1993 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1991 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/08/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 05/09/1991 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/28/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/18/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/18/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1988 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/09/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
SOLUTION;ORAL; 120MG/5ML;12MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 089450 | CHARTWELL |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 087508 | GENUS LIFESCIENCES |