Orange Book product · Brand (NDA)

CLOROTEKAL

CHLOROPROCAINE HYDROCHLORIDE

Brand (NDA)NDA 208791DISCN B BRAUN MEDICAL

Sep 26, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 26, 2017
8 yr 10 mo ago
Today
Patent 8969412 expires
Listed drug product patent expiration.
Sep 05, 2026
in 3 mo
Patent 9504666 expires
Listed drug product patent expiration.
Dec 11, 2033
in 7 yr 7 mo

Active ingredient

CHLOROPROCAINE HYDROCHLORIDE

Strength

50MG/5ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRATHECAL

TE code

Not listed

Application

NDA 208791

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
8969412	Sep 05, 2026	in 3 mo	ProductU-2609
9504666	Dec 11, 2033	in 7 yr 7 mo	Product