Orange Book product · Brand (NDA)

LIBRAX

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Brand (NDA)NDA 012750TE ABRX BAUSCH

View CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE family Open on FDA Orange Book

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Strength

5MG;2.5MG

Dosage form

CAPSULE

Route

ORAL

TE code

Application

NDA 012750

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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