Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075851
Company: MYLAN
Company: MYLAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXAPROZIN | OXAPROZIN | 600MG | TABLET;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 |
---|---|---|---|---|---|---|---|
08/17/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75851ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/10/2003 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/13/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/17/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-851_Oxaprozin_Prntlbl.pdf |