Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091292
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
11/30/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

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

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