Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216967
Company: ALEMBIC

Products on ANDA 216967

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 216967

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2022	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
03/19/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216967

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