Drugs@FDA: FDA-Approved Drugs
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | 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 |
---|---|---|---|---|---|---|---|
04/23/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076578s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/21/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
10/25/2019 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/25/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
10/25/2019 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/25/2019 | SUPPL-15 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/25/2019 | SUPPL-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/25/2019 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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03/19/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2014 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
01/21/2011 | SUPPL-8 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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11/19/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |