Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYLENOL W/ CODEINE NO. 1 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| TYLENOL W/ CODEINE NO. 2 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TYLENOL W/ CODEINE NO. 3 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TYLENOL W/ CODEINE NO. 4 | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/17/1977 | 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 |
|---|---|---|---|---|---|
| 10/29/2019 | SUPPL-64 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/18/2019 | SUPPL-63 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2019 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-60 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-59 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/24/2017 | SUPPL-58 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2019 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2014 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/15/2011 | SUPPL-52 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/11/2008 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 10/31/2007 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 05/31/2001 | SUPPL-46 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/2000 | SUPPL-43 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/23/1994 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1992 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 03/15/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 08/31/1990 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/31/1990 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1990 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1983 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1983 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |