Question 1

Is there a generic for Magnesium sulfate; potassium chloride; sodium sulfate?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Magnesium sulfate; potassium chloride; sodium sulfate, referencing the brand SUTAB. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Magnesium sulfate; potassium chloride; sodium sulfate?

Accepted Answer

SUTAB (NDA 213135, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Magnesium sulfate; potassium chloride; sodium sulfate?

Accepted Answer

The Orange Book lists 4 patents against Magnesium sulfate; potassium chloride; sodium sulfate products, with the earliest listed expiry in 2037. 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 Magnesium sulfate; potassium chloride; sodium sulfate are approved?

Accepted Answer

Magnesium sulfate; potassium chloride; sodium sulfate is approved in the following dosage form: tablet.

Patent	Expires	In	Type
11382864	Aug 04, 2037	in 11 yr 3 mo	U-3164
11033498	Aug 04, 2037	in 11 yr 3 mo	U-3164
11638697	Aug 04, 2037	in 11 yr 3 mo	Product
10143656	Aug 04, 2037	in 11 yr 3 mo	Product

Magnesium sulfate; potassium chloride; sodium sulfate

Brand (NDA) products · tablet

Generic (ANDA) products (1)

Listed patents (4)

Magnesium sulfate; potassium chloride; sodium sulfate — frequently asked questions

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