Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203203
Company: XIROMED

Products on ANDA 203203

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203203

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2016	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
04/06/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/06/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/06/2023	SUPPL-10	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
08/20/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/20/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
08/20/2020	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/20/2020	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203203

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	207394	ALKEM LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	207156	CHARTWELL MOLECULAR
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	091269	DR REDDYS LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	203083	HETERO LABS LTD III
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205868	INVENTIA
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090763	MYLAN PHARMS INC
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	201921	NATCO PHARMA LTD
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090331	SANDOZ
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	077255	TEVA PHARMS
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	202176	WOCKHARDT
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	203203	XIROMED
LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	202366	ZYDUS HLTHCARE

CAPSULE, DELAYED REL PELLETS;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	207394	ALKEM LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	207156	CHARTWELL MOLECULAR
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	091269	DR REDDYS LABS LTD
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	203083	HETERO LABS LTD III
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	205868	INVENTIA
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090763	MYLAN PHARMS INC
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	201921	NATCO PHARMA LTD
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	090331	SANDOZ
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	077255	TEVA PHARMS
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	202176	WOCKHARDT
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	203203	XIROMED
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	202366	ZYDUS HLTHCARE
PREVACID	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	Yes	AB	020406	TAKEDA PHARMS USA