Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091292
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 | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
05/20/2011 | 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 |
---|---|---|---|---|---|
12/13/2021 | SUPPL-16 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/13/2021 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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11/30/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2015 | SUPPL-3 | Labeling-Container/Carton Labels |
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.
SUSPENSION;ORAL; 1MG/7.5ML
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
IMODIUM A-D | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 019487 | J AND J CONSUMER INC |
LOPERAMIDE HYDROCHLORIDE | LOPERAMIDE HYDROCHLORIDE | 1MG/7.5ML | SUSPENSION;ORAL | Over-the-counter | No | 091292 | PERRIGO R AND D |