Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074091
Company: OHM LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;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
12/10/1992 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
09/12/2006 SUPPL-21 Labeling

Label is not available on this site.

10/16/2002 SUPPL-9 Labeling

Label is not available on this site.

01/17/2002 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

06/21/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2000 SUPPL-5 Labeling

Label is not available on this site.

05/13/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/27/1998 SUPPL-3 Labeling

Label is not available on this site.

07/18/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-1 Labeling

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.

TABLET;ORAL; 2MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
IMODIUM A-D LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter Yes 019860 J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 206548 AUROBINDO PHARMA LTD
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 073254 CONTRACT PHARMACAL
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 075232 L PERRIGO CO
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 076497 LNK
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE 2MG TABLET;ORAL Over-the-counter No 074091 OHM LABS

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