Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 250MG | 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 |
---|---|---|---|---|---|---|---|
12/20/1984 | 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 |
---|---|---|---|---|---|
07/08/2024 | SUPPL-63 | Labeling-Package Insert |
Label is not available on this site. |
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06/20/2024 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
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04/05/2022 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
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04/05/2022 | SUPPL-60 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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08/13/2019 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
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06/30/2014 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
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08/02/2013 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
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08/30/2001 | SUPPL-42 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/07/2000 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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03/23/2000 | SUPPL-38 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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06/08/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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03/06/1997 | SUPPL-36 | Labeling |
Label is not available on this site. |
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08/28/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
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07/08/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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08/16/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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02/05/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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11/14/1995 | SUPPL-31 | Labeling |
Label is not available on this site. |
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10/03/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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01/26/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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04/28/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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07/30/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/25/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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08/27/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
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03/04/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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03/04/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
METRONIDAZOLE
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 208681 | ALEMBIC |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 079067 | ALEMBIC PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 203974 | AUROBINDO PHARMA LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 206560 | CADILA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 209794 | CADILA PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 205245 | HERITAGE PHARMS INC |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070772 | INNOGENIX |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 209096 | LUPIN LTD |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070040 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 208162 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070027 | TEVA PHARMS USA |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 203458 | UNICHEM |
METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | No | AB | 070035 | WATSON LABS |