Drugs@FDA: FDA-Approved Drugs
Company: INNOGENIX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| METRONIDAZOLE | METRONIDAZOLE | 250MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 07/16/1986 | 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-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/06/2022 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2021 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2019 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/05/2019 | SUPPL-39 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/19/2016 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 03/28/2012 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/15/2005 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/28/2005 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 12/13/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/17/2001 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/02/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/22/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/15/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/03/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1989 | SUPPL-1 | Labeling |
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 |
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 |