Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078857
Company: NORVIUM BIOSCIENCE
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CELECOXIB | CELECOXIB | 50MG | CAPSULE;ORAL | Discontinued | None | No | No |
CELECOXIB | CELECOXIB | 100MG | CAPSULE;ORAL | Discontinued | None | No | No |
CELECOXIB | CELECOXIB | 200MG | CAPSULE;ORAL | Discontinued | None | No | No |
CELECOXIB | CELECOXIB | 400MG | 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 |
---|---|---|---|---|---|---|---|
02/11/2015 | ORIG-2 | Approval |
Label is not available on this site. |
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05/30/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2022 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/09/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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04/02/2019 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/16/2016 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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11/10/2015 | SUPPL-1 | Labeling-Container/Carton Labels |
Label is not available on this site. |