Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209837
Company: PERRIGO R AND D
Company: PERRIGO R AND D
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 09/05/2018 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/03/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET;ORAL; 2MG;125MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| IMODIUM MULTI-SYMPTOM RELIEF | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | Yes | 021140 | J AND J CONSUMER INC |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 211059 | AUROBINDO PHARMA LTD |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 209837 | PERRIGO R AND D |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 077500 | SUN PHARM INDS LTD |
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