Is there a generic for Sulfadiazine sodium?

The FDA Orange Book does not currently list an approved generic (ANDA) for Sulfadiazine sodium. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Sulfadiazine sodium?

SULFADIAZINE SODIUM (NDA 004054, LEDERLE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sulfadiazine sodium are approved?

Sulfadiazine sodium is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Sulfadiazine sodium

Sulfadiazine sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SULFADIAZINE SODIUM · NDA 004054

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
SULFADIAZINE SODIUM	LEDERLE	NDA 004054	—	Approved Prior to Jan 1, 1982

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.

Sulfadiazine sodium — frequently asked questions

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

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