Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;5MG | TABLET;ORAL | Discontinued | None | No | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 325MG;10MG | 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 |
---|---|---|---|---|---|---|---|
12/23/2008 | 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-34 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/04/2021 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/11/2019 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/21/2018 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-27 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/16/2016 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2016 | SUPPL-16 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/15/2016 | SUPPL-14 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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10/25/2013 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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06/27/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |