Drugs@FDA: FDA-Approved Drugs
Company: OHM LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | 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 |
---|---|---|---|---|---|---|---|
12/10/1992 | 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 |
---|---|---|---|---|---|
09/09/2020 | SUPPL-36 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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07/09/2021 | SUPPL-34 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/09/2021 | SUPPL-33 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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07/09/2021 | SUPPL-30 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/12/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
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10/16/2002 | SUPPL-9 | Labeling |
Label is not available on this site. |
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01/17/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/21/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/28/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/13/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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02/27/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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07/18/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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06/16/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
LOPERAMIDE HYDROCHLORIDE
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
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | Yes | 019860 | J AND J CONSUMER INC |
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 206548 | AUROBINDO PHARMA |
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 075232 | L PERRIGO CO |
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 076497 | LNK |
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 2MG | TABLET;ORAL | Over-the-counter | No | 074091 | OHM LABS |