Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208833
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CELECOXIB | CELECOXIB | 50MG | CAPSULE;ORAL | Prescription | BX | No | No |
CELECOXIB | CELECOXIB | 100MG | CAPSULE;ORAL | Prescription | BX | No | No |
CELECOXIB | CELECOXIB | 200MG | CAPSULE;ORAL | Prescription | BX | No | No |
CELECOXIB | CELECOXIB | 400MG | CAPSULE;ORAL | Prescription | BX | 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 |
---|---|---|---|---|---|---|---|
05/31/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/10/2023 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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01/10/2023 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/01/2019 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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04/02/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
CELECOXIB
There are no Therapeutic Equivalents.