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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207167
Company: AUROBINDO PHARMA LTD

Products on ANDA 207167

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	AB	No	No
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207167

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2024	SUPPL-2	Labeling-Package Insert, Labeling, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 207167

LANSOPRAZOLE

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	207167	AUROBINDO PHARMA LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	210465	DR REDDYS
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	202396	MYLAN
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	208784	TEVA PHARMS USA
LANSOPRAZOLE	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	200816	ZYDUS PHARMS
PREVACID	LANSOPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021428	TAKEDA PHARMS USA

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	207167	AUROBINDO PHARMA LTD
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	210465	DR REDDYS
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	202396	MYLAN
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	208784	TEVA PHARMS USA
LANSOPRAZOLE	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	No	AB	200816	ZYDUS PHARMS
PREVACID	LANSOPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL	Prescription	Yes	AB	021428	TAKEDA PHARMS USA

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