Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078778
Company: NOSTRUM LABS INC
Company: NOSTRUM LABS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | 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 |
---|---|---|---|---|---|---|---|
04/07/2014 | 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-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/01/2023 | SUPPL-11 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
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12/01/2023 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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12/01/2023 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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09/18/2018 | SUPPL-7 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/01/2023 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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06/29/2017 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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06/24/2016 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |