Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 213516
Company: JUBILANT

Products on ANDA 213516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TECHNETIUM TC-99M SULFUR COLLOID KIT	TECHNETIUM TC-99M SULFUR COLLOID KIT		SOLUTION;INJECTION, ORAL	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213516Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 213516

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL;
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company