Is there a generic for Sodium bicarbonate; tartaric acid?

The FDA Orange Book does not currently list an approved generic (ANDA) for Sodium bicarbonate; tartaric acid. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Sodium bicarbonate; tartaric acid?

BAROS (NDA 018509, MALLINCKRODT INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Sodium bicarbonate; tartaric acid are approved?

Sodium bicarbonate; tartaric acid is approved in the following dosage form: granule, effervescent.

FDA Orange Book · active-ingredient family

Sodium bicarbonate; tartaric acid

Sodium bicarbonate; tartaric acid is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BAROS · NDA 018509

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · granule, effervescent

Product	Applicant	Application	TE	Approved
BAROS	MALLINCKRODT INC	NDA 018509	—	Aug 07, 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.

Sodium bicarbonate; tartaric acid — frequently asked questions

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

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