Orange Book product · Brand (NDA)

DORAL

QUAZEPAM

Brand (NDA)NDA 018708RX GALT PHARMS

Dec 27, 1985

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 27, 1985
41 yr 1 mo ago
Today
Patent 7608616 expires
Listed method-of-use patent (U-1012) expiration.
Jun 03, 2028
in 2 yr

Active ingredient

QUAZEPAM

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 018708

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
7608616	Jun 03, 2028	in 2 yr	U-1012