Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077500
Company: SUN PHARM INDS LTD

Products on ANDA 077500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/06/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077500s000_ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2022	SUPPL-8	Labeling-Container/Carton Labels		Label is not available on this site.
04/14/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/14/2020	SUPPL-3	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 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;ORAL; 2MG;125MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IMODIUM MULTI-SYMPTOM RELIEF	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	Yes	021140	J AND J CONSUMER INC
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	211059	AUROBINDO PHARMA LTD
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	213484	BIONPHARMA
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	214541	GUARDIAN DRUG
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	211438	HETERO LABS LTD V
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	209837	PERRIGO R AND D
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE	LOPERAMIDE HYDROCHLORIDE; SIMETHICONE	2MG;125MG	TABLET;ORAL	Over-the-counter	No	077500	SUN PHARM INDS LTD