Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS MID ATLANTIC
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/1978 | 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-81 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-80 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-79 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-78 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-77 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-76 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2018 | SUPPL-75 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-74 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-73 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-72 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 02/14/2017 | SUPPL-71 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2015 | SUPPL-70 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/27/2008 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-47 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/05/2000 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/02/1997 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/1994 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1993 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 07/16/1993 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1993 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1990 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 04/06/1992 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1990 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/16/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 05/18/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/19/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1987 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |