Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209256
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PIROXICAM | PIROXICAM | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
PIROXICAM | PIROXICAM | 20MG | 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 |
---|---|---|---|---|---|---|---|
08/11/2017 | 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 |
---|---|---|---|---|---|
02/27/2024 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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02/27/2024 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/17/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |