Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074352
Company: SAPTALIS PHARMS
Company: SAPTALIS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 11/17/1995 | 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 |
|---|---|---|---|---|---|
| 02/27/2015 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/19/2001 | SUPPL-1 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |