Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202588
Company: SANDOZ

Products on ANDA 202588

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202588

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2014	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
08/16/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/18/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/18/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/04/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/04/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202588

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL; 500MG;500MG;30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	206006	RISING
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)	AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE	500MG;500MG;30MG	CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	No	AB	202588	SANDOZ