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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205654
Company: ACTAVIS MID ATLANTIC

Products on ANDA 205654

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205654

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/14/2020	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
06/17/2025	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/22/2024	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/22/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/22/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205654

MESALAMINE

SUPPOSITORY;RECTAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CANASA	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	Yes	AB	021252	ABBVIE
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	205654	ACTAVIS MID ATLANTIC
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	213377	ANNORA PHARMA
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	208362	J MOLNER
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	204354	QUAGEN
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	207448	RISING
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	219028	RISING
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	202065	SANDOZ
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	208953	ZYDUS PHARMS

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