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Product safetyFDAUnited StatesImports

Determination That SULFADIAZINE (Sulfadiazine) Tablet, 500 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

29 September 2026

In plain English

FDA has determined that Sulfadiazine tablet, 500 mg, was not withdrawn for safety or effectiveness reasons, allowing approval of ANDAs for this drug if other requirements are met.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
29 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) has determined that SULFADIAZINE (sulfadiazine) tablet, 500 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for SULFADIAZINE (sulfadiazine) tablet, 500 mg, if all other legal and regulatory requirements are met.

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