Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070039
Company: STRIDES PHARMA
Company: STRIDES PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 500MG | 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 |
---|---|---|---|---|---|---|---|
01/29/1985 | 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 |
---|---|---|---|---|---|
01/05/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
03/31/2022 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
08/19/2021 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
07/29/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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04/16/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/01/1988 | SUPPL-8 | Bioequivalence |
Label is not available on this site. |
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06/16/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/23/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/23/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
METRONIDAZOLE
TABLET;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 208681 | ALEMBIC |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 079067 | ALEMBIC PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 203974 | AUROBINDO PHARMA LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 206560 | CADILA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 209794 | CADILA PHARMS LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 205245 | HERITAGE PHARMS INC |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070772 | INNOGENIX |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 209096 | LUPIN LTD |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070033 | PLIVA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070039 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 208162 | STRIDES PHARMA |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 203458 | UNICHEM |
METRONIDAZOLE | METRONIDAZOLE | 500MG | TABLET;ORAL | Prescription | No | AB | 070044 | WATSON LABS INC |