Is there a generic for Silver sulfadiazine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Silver sulfadiazine. It is available as 4 brand (NDA) applications.

What is the reference-listed drug for Silver sulfadiazine?

SSD (NDA 018578, DR REDDYS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Silver sulfadiazine are approved?

Silver sulfadiazine is approved in the following dosage forms: cream, dressing.

FDA Orange Book · active-ingredient family

Silver sulfadiazine

Silver sulfadiazine is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SSD · NDA 018578

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · cream, dressing

Product	Applicant	Application	TE	Approved
SSDRLD×2	DR REDDYS	NDA 018578	AB	Feb 25, 1982
SILVADENERLD	KING PHARMS LLC	NDA 017381	AB	Approved Prior to Jan 1, 1982
SILDAFLO	FRANKLIN PHARMS	NDA 019608	—	Nov 30, 1989
THERMAZENE	THEPHARMANETWORK LLC	NDA 018810	AB	Dec 23, 1985

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Silver sulfadiazine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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