Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208633
Company: AMNEAL PHARMS CO
Company: AMNEAL PHARMS CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
05/04/2017 | 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 |
---|---|---|---|---|---|
10/07/2022 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
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10/07/2022 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/07/2022 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
OXAPROZIN
TABLET;ORAL; 600MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DAYPRO | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | Yes | AB | 018841 | PFIZER |
OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 208633 | AMNEAL PHARMS CO |
OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075987 | CHARTWELL |
OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075855 | DR REDDYS LABS LTD |
OXAPROZIN | OXAPROZIN | 600MG | TABLET;ORAL | Prescription | No | AB | 075845 | PANGEA |