Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076029
Company: PERRIGO
Company: PERRIGO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET, CHEWABLE;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 |
|---|---|---|---|---|---|---|---|
| 08/30/2002 | 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 |
|---|---|---|---|---|---|
| 07/09/2021 | SUPPL-31 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/30/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 06/29/2007 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/2007 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/06/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |