Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071594
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FUROSEMIDE | FUROSEMIDE | 80MG | 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 |
---|---|---|---|---|---|---|---|
02/09/1988 | 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 |
---|---|---|---|---|---|
04/07/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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01/13/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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02/12/1990 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
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05/17/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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11/19/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/15/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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11/15/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |