Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
06/19/2002 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75977lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75977ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075977_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/18/2023 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/18/2023 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/22/2024 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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12/07/2023 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/07/2023 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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12/07/2023 | SUPPL-23 | Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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12/07/2023 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/07/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-17 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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12/07/2023 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/07/2023 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/09/2015 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/22/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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04/08/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
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10/30/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/19/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75977lbl.pdf |
TRAMADOL HYDROCHLORIDE
TABLET;ORAL; 50MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202075 | ACI |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 076003 | AMNEAL PHARMS |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075981 | APOTEX |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 203494 | AUROBINDO PHARMA LTD |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091498 | CSPC OUYI PHARM CO |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 201973 | IPCA LABS LTD |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 206706 | MERRO PHARM USA |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 208708 | RUBICON |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075964 | SUN PHARM INDS INC |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 075977 | TEVA |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 211825 | UNICHEM |
TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 090404 | ZYDUS PHARMS USA INC |