Is there a generic for Chloramphenicol sodium succinate?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Chloramphenicol sodium succinate, referencing the brand CHLOROMYCETIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chloramphenicol sodium succinate?

CHLOROMYCETIN (NDA 050155, PARKEDALE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chloramphenicol sodium succinate are approved?

Chloramphenicol sodium succinate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Chloramphenicol sodium succinate

Chloramphenicol sodium succinate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CHLOROMYCETIN · NDA 050155

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CHLOROMYCETINRLD	PARKEDALE	NDA 050155	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
CHLORAMPHENICOL	ELKINS SINN	ANDA 062406	—	Nov 09, 1982
CHLORAMPHENICOL SODIUM SUCCINATE	FRESENIUS KABI USA	ANDA 062365	—	Aug 25, 1982
CHLORAMPHENICOL SODIUM SUCCINATE	GRUPPO LEPETIT	ANDA 062278	—	Approved Prior to Jan 1, 1982
MYCHEL-S	ANGUS	ANDA 060132	—	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.

Chloramphenicol sodium succinate — frequently asked questions

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

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