Drugs@FDA: FDA-Approved Drugs
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | 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 |
---|---|---|---|---|---|---|---|
07/16/1992 | 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 |
---|---|---|---|---|---|
10/31/2024 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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12/15/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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10/07/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-11 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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09/20/2018 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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08/29/2017 | SUPPL-9 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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05/21/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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12/23/2014 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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08/11/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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08/28/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |