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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018829
Company: CHARTWELL MOLECULES

Medication Guide

Products on NDA 018829

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	AB	No	No
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018829

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/1984	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018829Orig1s023ltr.pdf
05/09/2016	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018829Orig1s022ltr.pdf
07/26/1996	SUPPL-21	Labeling		Label is not available on this site.
06/07/1996	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
05/27/1992	SUPPL-19	Labeling		Label is not available on this site.
04/29/1991	SUPPL-18	Labeling		Label is not available on this site.
06/08/1989	SUPPL-17	Labeling		Label is not available on this site.
03/21/1989	SUPPL-16	Labeling		Label is not available on this site.
11/09/1988	SUPPL-15	Labeling		Label is not available on this site.
05/02/1989	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/28/1987	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/14/1986	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/14/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/19/1985	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 018829

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf
04/28/2021	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018829s023lbl.pdf
05/09/2016	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf
05/09/2016	SUPPL-22	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018829s022lbl.pdf

Therapeutic Equivalents for NDA 018829

INDOMETHACIN

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	018829	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	070651	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	091276	GLENMARK PHARMS LTD
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	091240	HETERO LABS LTD III
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	070674	SANDOZ
INDOMETHACIN	INDOMETHACIN	50MG	CAPSULE;ORAL	Prescription	No	AB	090403	ZYDUS LIFESCIENCES

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	018829	CHARTWELL MOLECULES
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091276	GLENMARK PHARMS LTD
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	091240	HETERO LABS LTD III
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	070673	SANDOZ
INDOMETHACIN	INDOMETHACIN	25MG	CAPSULE;ORAL	Prescription	No	AB	090403	ZYDUS LIFESCIENCES

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