Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074194
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Discontinued 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
10/30/1992 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
11/20/2001 SUPPL-8 Labeling

Label is not available on this site.

01/24/1997 SUPPL-6 Labeling

Label is not available on this site.

01/24/1997 SUPPL-5 Labeling

Label is not available on this site.

06/05/1995 SUPPL-4 Labeling

Label is not available on this site.

03/01/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/01/1994 SUPPL-1 Labeling

Label is not available on this site.

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