Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208953
Company: ZYDUS PHARMS

Products on ANDA 208953

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 208953

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208953Orig1s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/27/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
10/28/2022	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/28/2022	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208953

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	208362	AMRING PHARMS
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	213377	ANNORA PHARMA
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	204354	MYLAN
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	207448	PHARM SOURCING
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	202065	SANDOZ
MESALAMINE	MESALAMINE	1GM	SUPPOSITORY;RECTAL	Prescription	No	AB	208953	ZYDUS PHARMS