Orange Book product · Brand (NDA)

PREVDUO

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Brand (NDA)NDA 216903RX AZURITY

Feb 23, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 23, 2023
3 yr 4 mo ago
Today
Patent 10456354 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 11110054 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 11938217 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 12151020 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo
Patent 12383491 expires
Listed drug product patent expiration.
Oct 25, 2038
in 12 yr 6 mo

Active ingredient

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Strength

0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216903

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
10456354	Oct 25, 2038	in 12 yr 6 mo	Product
11110054	Oct 25, 2038	in 12 yr 6 mo	Product
11938217	Oct 25, 2038	in 12 yr 6 mo	Product
12151020	Oct 25, 2038	in 12 yr 6 mo	Product
12383491	Oct 25, 2038	in 12 yr 6 mo	Product