Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089828
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 09/30/1988 | 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-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-35 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-29 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-26 | Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/11/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/18/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/10/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/16/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |