Is Atrovent still available?

Atrovent (NDA 020393) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Atrovent have a generic?

Yes. The Orange Book lists 28 approved generic (ANDA) applications sharing Atrovent's active ingredient (Ipratropium Bromide). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Atrovent's FDA application number?

Atrovent is approved under NDA 020393, held by Boehringer Ingelheim.

Orange Book product · Brand (NDA)

Atrovent

Ipratropium Bromide

Brand (NDA)NDA 020393DiscontinuedRLD Boehringer Ingelheim

Approved

Oct 20, 1995

Application

Brand (NDA)

TE code

Not listed

Listed patents

Atrovent (Ipratropium Bromide) is Boehringer Ingelheim's brand-name drug, approved by the FDA under NDA 020393 in 1995. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 28 approved generics share this drug's active ingredient.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Oct 20, 1995
31 yr 2 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

IPRATROPIUM BROMIDE

Strength

0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 020393

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Ipratropium Bromide family

Orange Book patent file

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.

Atrovent — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Ipratropium Bromide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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