Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074091
Company: OHM LABS

Products on ANDA 074091

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074091

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
09/09/2020	SUPPL-36	Labeling-Container/Carton Labels		Label is not available on this site.
07/09/2021	SUPPL-34	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/09/2021	SUPPL-33	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/09/2021	SUPPL-30	Labeling-Container/Carton Labels		Label is not available on this site.
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.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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	KENVUE BRANDS
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET;ORAL	Over-the-counter	No	206548	AUROBINDO PHARMA
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	220153	MARKSANS PHARMA
LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	2MG	TABLET;ORAL	Over-the-counter	No	074091	OHM LABS