Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 211438
Company: HETERO LABS LTD V
Company: HETERO LABS LTD V
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 |
---|---|---|---|---|---|---|---|
06/17/2021 | ORIG-1 | Approval | STANDARD |
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 | 213484 | BIONPHARMA |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 214541 | GUARDIAN DRUG |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 211438 | HETERO LABS LTD V |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | LOPERAMIDE HYDROCHLORIDE; SIMETHICONE | 2MG;125MG | TABLET;ORAL | Over-the-counter | No | 209837 | PERRIGO R AND D |