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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202194
Company: DR REDDYS LABS LTD

Products on ANDA 202194

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 202194

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	Not Applicable		Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202194s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202194Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2024	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
05/14/2024	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
04/12/2022	SUPPL-11	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/07/2020	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
10/07/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/07/2020	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/18/2013	SUPPL-2	Labeling-Package Insert, Labeling-Container/Carton Labels		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
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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