Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219997
Company: DIFGEN PHARMS

Products on ANDA 219997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MESALAMINE	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219997

MESALAMINE

CAPSULE, EXTENDED RELEASE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESALAMINE	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	219997	DIFGEN PHARMS
PENTASA	MESALAMINE	250MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020049	TAKEDA PHARMS USA

CAPSULE, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESALAMINE	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	219997	DIFGEN PHARMS
MESALAMINE	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214585	SUN PHARM
PENTASA	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020049	TAKEDA PHARMS USA