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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213191
Company: TEVA PHARMS INC

Products on ANDA 213191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213191

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213191

MESALAMINE

TABLET, DELAYED RELEASE;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	215067	AMNEAL
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213191	TEVA PHARMS INC
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203286	ZYDUS PHARMS

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