An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203286
Company: ZYDUS PHARMS

Products on ANDA 203286

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2017	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203286Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/203286Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/01/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/01/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/01/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
03/01/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
11/18/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/18/2021	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/18/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/26/2018	SUPPL-2	Labeling-Proprietary Name Change		Label is not available on this site.
06/26/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203286

MESALAMINE

TABLET, DELAYED RELEASE;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	213191	TEVA PHARMS INC
MESALAMINE	MESALAMINE	800MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203286	ZYDUS PHARMS

Top