Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076522
Company: CHARTWELL RX
Company: CHARTWELL RX
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 375MG | CAPSULE;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 |
---|---|---|---|---|---|---|---|
01/29/2004 | 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 |
---|---|---|---|---|---|
11/27/2023 | SUPPL-11 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
10/22/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
06/27/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
01/21/2005 | SUPPL-2 | Labeling |
Label is not available on this site. |
METRONIDAZOLE
CAPSULE;ORAL; 375MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLAGYL | METRONIDAZOLE | 375MG | CAPSULE;ORAL | Prescription | Yes | AB | 020334 | PFIZER |
METRONIDAZOLE | METRONIDAZOLE | 375MG | CAPSULE;ORAL | Prescription | No | AB | 079065 | ALEMBIC |
METRONIDAZOLE | METRONIDAZOLE | 375MG | CAPSULE;ORAL | Prescription | No | AB | 076522 | CHARTWELL RX |