Sodium Pertechnetate Tc 99m

NDA 17321, held by Sun Pharm Inds Inc. Technetium Tc-99m Sodium Pertechnetate.

As of Nov 15, 2026, NDA 17321 (Sodium Pertechnetate Tc 99m), held by Sun Pharm Inds Inc, was first approved by FDA on Oct 20, 1976, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 20, 1976
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

3 strengths and forms


Sodium Pertechnetate Tc 99m12mCi/ML · solution;injection, oral	Technetium Tc-99m Sodium Pertechnetate	Discontinued
Sodium Pertechnetate Tc 99m24mCi/ML · solution;injection, oral	Technetium Tc-99m Sodium Pertechnetate	Discontinued
Sodium Pertechnetate Tc 99m48mCi/ML · solution;injection, oral	Technetium Tc-99m Sodium Pertechnetate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Jan 27, 1986	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 27, 1981	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 20, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17321
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters