Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206885
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
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 |
---|---|---|---|---|---|---|---|
05/02/2017 | ORIG-1 | Approval | STANDARD |
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-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/08/2023 | SUPPL-23 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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06/07/2023 | SUPPL-21 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
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12/08/2023 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/08/2023 | SUPPL-18 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/08/2023 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/08/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-10 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/08/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |