Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085883
Company: ACTAVIS MID ATLANTIC
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPITAL AND CODEINE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SUSPENSION;ORAL | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 01/08/1979 | 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 |
|---|---|---|---|---|---|
| 12/16/2016 | SUPPL-41 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-40 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/04/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/22/2000 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/1998 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/08/1991 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/03/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/02/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |