Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214585
Company: SUN PHARM

Products on ANDA 214585

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/11/2022	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214585Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214585Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/214585Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/01/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/12/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214585

MESALAMINE

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	214585	SUN PHARM
PENTASA	MESALAMINE	500MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	020049	TAKEDA PHARMS USA