Orange Book product · Brand (NDA)

FUROSCIX

FUROSEMIDE

Brand (NDA)NDA 209988RX SCPHARMACEUTICALS

Oct 07, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 07, 2022
3 yr 9 mo ago
Today
Patent 10272064 expires
Listed drug product patent expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 11433044 expires
Listed method-of-use patent (U-3462) expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 12370168 expires
Listed drug product patent expiration.
Apr 03, 2034
in 7 yr 11 mo
Patent 9884039 expires
Listed method-of-use patent (U-3462) expiration.
Apr 03, 2034
in 7 yr 11 mo

Active ingredient

FUROSEMIDE

Strength

80MG/10ML (8MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 209988

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10272064	Apr 03, 2034	in 7 yr 11 mo	Product
11433044	Apr 03, 2034	in 7 yr 11 mo	U-3462
12370168	Apr 03, 2034	in 7 yr 11 mo	ProductU-3462
9884039	Apr 03, 2034	in 7 yr 11 mo	U-3462