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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206548
Company: AUROBINDO PHARMA

Products on ANDA 206548

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 206548

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/09/2021	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
07/09/2021	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
07/09/2021	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
07/09/2021	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/28/2019	SUPPL-1	Labeling-Container/Carton Labels		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	J AND J CONSUMER INC
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	074091	OHM LABS

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