Drugs@FDA: FDA-Approved Drugs
Company: WOCKHARDT BIO AG
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 07/22/1981 | 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 |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-39 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-33 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 02/07/2018 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-30 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/30/2013 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/12/2007 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 09/21/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 05/17/2005 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/09/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 12/20/1993 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 03/03/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/03/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/15/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1987 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/16/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |