Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073079
Company: ALLIED
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 1MG/5ML SOLUTION;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
04/30/1992 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
10/14/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-5 Labeling

Label is not available on this site.

08/28/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/29/1993 SUPPL-2 Labeling

Label is not available on this site.

03/29/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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