Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217337
Company: SINOTHERAPEUTICS INC

Products on ANDA 217337

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217337

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/12/2023	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
05/29/2025	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217337

MESALAMINE

TABLET, DELAYED RELEASE;ORAL; 1.2GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIALDA	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022000	TAKEDA PHARMS USA
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203817	ACTAVIS LABS FL
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216334	ANNORA PHARMA
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217337	SINOTHERAPEUTICS INC
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211858	SUN PHARM
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091640	ZYDUS PHARMS