Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217883
Company: NOVITIUM PHARMA

Products on ANDA 217883

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDOMETHACIN	INDOMETHACIN	25MG/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217883

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2025	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 217883

INDOMETHACIN

SUSPENSION;ORAL; 25MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
INDOCIN	INDOMETHACIN	25MG/5ML	SUSPENSION;ORAL	Prescription	Yes	AB	018332	COSETTE
INDOMETHACIN	INDOMETHACIN	25MG/5ML	SUSPENSION;ORAL	Prescription	No	AB	217883	NOVITIUM PHARMA