Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207873
Company: TEVA PHARMS USA

Products on ANDA 207873

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/09/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207873Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/20/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207873

MESALAMINE

CAPSULE, DELAYED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DELZICOL	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	Yes	AB	204412	ABBVIE
MESALAMINE	MESALAMINE	400MG	CAPSULE, DELAYED RELEASE;ORAL	Prescription	No	AB	207873	TEVA PHARMS USA