Question 1

Is there a generic for Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate, referencing the brand OSMOPREP. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate?

Accepted Answer

OSMOPREP (NDA 021892, SALIX PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate?

Accepted Answer

The Orange Book lists 1 patent against Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate are approved?

Accepted Answer

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate is approved in the following dosage form: tablet.

Product	Applicant	Application	TE	Approved
OSMOPREPRLD	SALIX PHARMS	NDA 021892	—	Mar 16, 2006
VISICOL	SALIX PHARMS	NDA 021097	—	Sep 21, 2000

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Listed patents (1)

Sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate — frequently asked questions

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