Orange Book product · Brand (NDA)

MOXATAG

AMOXICILLIN

Brand (NDA)NDA 050813DISCN PRAGMA

Jan 23, 2008

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 23, 2008
18 yr 8 mo ago
Today
Patent 8357394 expires
Listed drug product patent expiration.
Dec 08, 2026
in 6 mo
Patent 8778924 expires
Listed drug substance patent expiration.
Dec 08, 2026
in 6 mo
Patent 8299052 expires
Listed method-of-use patent (U-1304) expiration.
May 07, 2027
in 11 mo

Active ingredient

AMOXICILLIN

Strength

775MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 050813

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8357394	Dec 08, 2026	in 6 mo	Product
8778924	Dec 08, 2026	in 6 mo	SubstanceProductU-897
8299052	May 07, 2027	in 11 mo	U-1304