Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078783
Company: STRIDES PHARMA INTL
Company: STRIDES PHARMA INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 100MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 200MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| TRAMADOL HYDROCHLORIDE | TRAMADOL HYDROCHLORIDE | 300MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 11/13/2009 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-16 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 10/21/2025 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/15/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/10/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2021 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/09/2019 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/18/2018 | SUPPL-8 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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| 08/29/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/21/2017 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/21/2017 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/20/2011 | SUPPL-1 | Efficacy-New Dosing Regimen |
Label is not available on this site. |