Drugs@FDA: FDA-Approved Drugs
Company: PLIVA
| 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 |
|---|---|---|---|---|---|---|---|
| 12/06/1984 | 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 |
|---|---|---|---|---|---|
| 03/22/2022 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2022 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2019 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2019 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/05/2017 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2014 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2014 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2010 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/29/2001 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/27/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/21/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/11/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/01/1992 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/12/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/22/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1985 | SUPPL-1 | 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 |