Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | No | No |
PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED 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 |
---|---|---|---|---|---|---|---|
08/02/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/08/2015 | SUPPL-16 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
12/05/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
12/05/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
05/03/2013 | SUPPL-10 | Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
10/03/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
10/03/2012 | SUPPL-8 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
07/31/2011 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
03/31/2011 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
03/31/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
05/21/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
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