Drugs@FDA: FDA-Approved Drugs
Company: AMNEAL PHARMS
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 | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/09/2009 | 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 |
---|---|---|---|---|---|
12/19/2023 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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12/15/2023 | SUPPL-27 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/15/2023 | SUPPL-25 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/15/2023 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/15/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-16 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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04/26/2018 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/26/2018 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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07/27/2016 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/27/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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07/08/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/13/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
TABLET;ORAL; 325MG;37.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 202076 | ALKEM LABS LTD |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 090485 | AMNEAL PHARMS |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 207152 | AUROBINDO PHARMA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 201952 | MICRO LABS LTD INDIA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 077858 | RISING |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 077184 | SUN PHARM INDS INC |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | 325MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 090460 | ZYDUS PHARMS USA INC |