Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090901
Company: JUBILANT GENERICS
Company: JUBILANT GENERICS
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 |
---|---|---|---|---|---|---|---|
08/30/2011 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/04/2020 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/04/2020 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/04/2020 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/07/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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12/21/2014 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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12/21/2014 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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05/30/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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10/16/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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10/16/2012 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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10/16/2012 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Patient Package Insert |
Label is not available on this site. |