Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201679
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NITROFURANTOIN | NITROFURANTOIN | 25MG/5ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 05/11/2011 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/28/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/25/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |