Orange Book product · Brand (NDA)

GLEOLAN

AMINOLEVULINIC ACID HYDROCHLORIDE

Brand (NDA)NDA 208630RX NXDC

View AMINOLEVULINIC ACID HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Jun 06, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 06, 2017
9 yr 2 mo ago
Today

Pharmaceutical detail

Active ingredient

AMINOLEVULINIC ACID HYDROCHLORIDE

Strength

1.5GM/VIAL

Dosage form

FOR SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 208630

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.

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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