Orange Book product · Brand (NDA)

SPIRIVA RESPIMAT

TIOTROPIUM BROMIDE

Brand (NDA)NDA 021936RX BOEHRINGER INGELHEIM

View TIOTROPIUM BROMIDE family Open on FDA Orange Book

At a glance

Sep 15, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Sep 15, 2015
10 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

TIOTROPIUM BROMIDE

Strength

EQ 0.00125MG BASE/INH

Dosage form

SPRAY, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 021936

Product number

002

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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