Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| METRONIDAZOLE | METRONIDAZOLE | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/30/1981 | 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 |
|---|---|---|---|---|---|
| 12/14/2004 | SUPPL-37 | Labeling |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
Label is not available on this site. |
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| 04/19/2004 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 07/29/2002 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 09/12/2001 | SUPPL-32 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 12/23/1999 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/06/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/26/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/26/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/01/1997 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/29/1996 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/30/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/30/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 11/03/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 11/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 02/26/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 05/10/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |