Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS INC
| 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 |
|---|---|---|---|---|---|---|---|
| 02/08/1985 | 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 |
|---|---|---|---|---|---|
| 04/05/2022 | SUPPL-60 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/05/2022 | SUPPL-59 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/29/2019 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2014 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2013 | SUPPL-55 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-41 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/23/2000 | SUPPL-37 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/06/1997 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1995 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/30/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/14/1990 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/23/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/25/1986 | 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 |