Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076029
Company: PERRIGO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET, CHEWABLE;ORAL Over-the-counter None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/30/2002 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
04/30/2009 SUPPL-25 Labeling

Label is not available on this site.

06/29/2007 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/2007 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

11/06/2007 SUPPL-8 Labeling

Label is not available on this site.

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, CHEWABLE;ORAL; 2MG;125MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE LOPERAMIDE HYDROCHLORIDE; SIMETHICONE 2MG;125MG TABLET, CHEWABLE;ORAL Over-the-counter No 076029 PERRIGO

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