Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078879
Company: HERITAGE
Company: HERITAGE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TEMOZOLOMIDE | TEMOZOLOMIDE | 5MG | CAPSULE;ORAL | Discontinued | None | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 250MG | CAPSULE;ORAL | Discontinued | None | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 140MG | CAPSULE;ORAL | Discontinued | None | No | No |
TEMOZOLOMIDE | TEMOZOLOMIDE | 180MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
03/01/2010 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078879Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/20/2022 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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11/14/2019 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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11/23/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/23/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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11/23/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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04/30/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/13/2011 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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07/28/2010 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |