Orange Book product · Brand (NDA)

DEHYDRATED ALCOHOL

Brand (NDA)NDA 214988RX ROYAL PHARMS

View DEHYDRATED ALCOHOL family Open on FDA Orange Book

At a glance

Oct 23, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 23, 2025
8 mo ago
Today
Exclusivity ends · ODE-521
Orphan-drug exclusivity (7 years)
Oct 23, 2032
in 6 yr 5 mo

Pharmaceutical detail

Active ingredient

DEHYDRATED ALCOHOL

Strength

98% (5ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214988

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)

ODE-521Orphan-drug exclusivity (7 years)
Oct 23, 2032
in 6 yr 5 mo

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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