Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091640
Company: ZYDUS PHARMS

Products on ANDA 091640

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091640

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/05/2017	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/091640Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/091640Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/091640Orig1_Approval_pkg.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2024	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
05/01/2023	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/27/2022	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/07/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/19/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/19/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/19/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
05/19/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 091640

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/091640Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 091640

MESALAMINE

TABLET, DELAYED RELEASE;ORAL; 1.2GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LIALDA	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	022000	TAKEDA PHARMS USA
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	203817	ACTAVIS LABS FL
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216334	ANNORA PHARMA
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217337	SINOTHERAPEUTICS INC
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211858	SUN PHARM
MESALAMINE	MESALAMINE	1.2GM	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091640	ZYDUS PHARMS