Sildaflo

NDA 19608, held by Franklin Pharms. Silver Sulfadiazine.

As of Nov 13, 2026, NDA 19608 (Sildaflo), held by Franklin Pharms, was first approved by FDA on Nov 30, 1989, with 2 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1989
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
Nov 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sildaflo1% · dressing;topical	Silver Sulfadiazine	Discontinued

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Feb 25, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Apr 13, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 30, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19608
Drugs@FDA: Overview at FDA
Company: Franklin Pharmaceuticals

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