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Drugs@FDA: FDA-Approved Drugs

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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	215067	AMNEAL
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

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