Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070651
Company: CHARTWELL MOLECULES

Products on ANDA 070651

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070651

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/1986	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-16	Labeling-Package Insert		Label is not available on this site.
04/26/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/26/1996	SUPPL-13	Labeling		Label is not available on this site.
06/07/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/10/1991	SUPPL-11	Labeling		Label is not available on this site.
07/16/1991	SUPPL-10	Labeling		Label is not available on this site.
05/02/1989	SUPPL-9	Labeling		Label is not available on this site.
02/02/1989	SUPPL-8	Labeling		Label is not available on this site.
10/26/1988	SUPPL-7	Labeling		Label is not available on this site.
05/02/1989	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/27/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/15/1986	SUPPL-3	Labeling		Label is not available on this site.
03/24/1987	SUPPL-2	Labeling		Label is not available on this site.
03/21/1986	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070651

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