Orange Book product · Brand (NDA)

NEXTERONE

AMIODARONE HYDROCHLORIDE

Brand (NDA)NDA 022325RX BAXTER HLTHCARE

Nov 16, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 16, 2010
15 yr 10 mo ago
Today
Patent 10117951 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 10177951 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9200088 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo

Active ingredient

AMIODARONE HYDROCHLORIDE

Strength

150MG/100ML (1.5MG/ML)

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 022325

Product number

002

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
10117951	Mar 13, 2029	in 2 yr 9 mo	Product
10177951	Mar 13, 2029	in 2 yr 9 mo	Product
7635773	Mar 13, 2029	in 2 yr 9 mo	Product
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
9200088	Mar 13, 2029	in 2 yr 9 mo	Product
9750822	Mar 13, 2029	in 2 yr 9 mo	Product
9493582	Feb 27, 2033	in 6 yr 10 mo	Product