Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 070040
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 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. |
||
| 04/16/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/07/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 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; 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 |