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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202319
Company: PERRIGO R AND D

Products on ANDA 202319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202319s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
08/20/2020	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
09/18/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/05/2013	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/05/2013	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

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

LANSOPRAZOLE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE, DELAYED REL PELLETS;ORAL; 15MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202194	DR REDDYS LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202727	GLENMARK PHARMS INC
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	203306	NATCO
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	No	202319	PERRIGO R AND D
PREVACID 24 HR	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Over-the-counter	Yes	022327	PERRIGO PHARMA INTL

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