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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207271
Company: MYLAN

Products on ANDA 207271

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207271

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207271Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/01/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/03/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/03/2022	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207271

MESALAMINE

CAPSULE, EXTENDED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
APRISO	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	022301	SALIX
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216967	ALEMBIC
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214242	ALKEM LABS LTD
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	217533	AMTA
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	214477	AUROBINDO PHARMA LTD
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	207271	MYLAN
MESALAMINE	MESALAMINE	375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208954	ZYDUS PHARMS

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