An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203306
Company: NATCO

Products on ANDA 203306

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 203306

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/13/2016	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
07/21/2020	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/21/2020	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/21/2020	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient 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

Top