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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075232
Company: L PERRIGO CO

Products on ANDA 075232

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 075232

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75232ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/08/2020	SUPPL-46	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/08/2020	SUPPL-44	Labeling-Package Insert		Label is not available on this site.
10/23/2007	SUPPL-20	Labeling		Label is not available on this site.
10/04/2002	SUPPL-6	Labeling		Label is not available on this site.
10/04/2002	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/04/2002	SUPPL-4	Labeling		Label is not available on this site.
10/04/2002	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/04/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
10/04/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Labels for ANDA 075232

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/06/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/75-232_Loperamide_prntlbl.pdf

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

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