Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087769
Company: IVAX PHARMS
Company: IVAX PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SULFINPYRAZONE | SULFINPYRAZONE | 100MG | 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 |
---|---|---|---|---|---|---|---|
06/01/1982 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/06/1995 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/09/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
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09/16/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |