Is there a generic for Mannitol; sorbitol?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Mannitol; sorbitol, referencing the brand SORBITOL-MANNITOL IN PLASTIC CONTAINER. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mannitol; sorbitol?

SORBITOL-MANNITOL IN PLASTIC CONTAINER (NDA 018316, OTSUKA ICU MEDCL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mannitol; sorbitol are approved?

Mannitol; sorbitol is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Mannitol; sorbitol

Mannitol; sorbitol is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:SORBITOL-MANNITOL IN PLASTIC CONTAINER · NDA 018316

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
SORBITOL-MANNITOL IN PLASTIC CONTAINERRLD	OTSUKA ICU MEDCL	NDA 018316	—	Approved Prior to Jan 1, 1982
SORBITOL-MANNITOL IN PLASTIC CONTAINER	HOSPIRA	NDA 017636	—	Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
SORBITOL-MANNITOL	HOSPIRA	ANDA 080224	—	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.

Mannitol; sorbitol — frequently asked questions

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

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