Orange Book product · Brand (NDA)

REXTOVY

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 208969RX AMPHASTAR PHARMS INC

View NALOXONE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Mar 07, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 07, 2023
3 yr 4 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
Mar 07, 2026
3 mo ago
Today

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

4MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 208969

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Marketing exclusivity (1)

NPNew product exclusivity (3 years)
Mar 07, 2026
3 mo ago

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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