Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076505
Company: ABLE
Company: ABLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
METRONIDAZOLE | METRONIDAZOLE | 375MG | CAPSULE;ORAL | Discontinued | None | 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 |
---|---|---|---|---|---|---|---|
11/13/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076505_S000_Metronidazole Capsules_ORIGINAL AP.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2005 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/16/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |