Is Aerobid still available?

Aerobid (NDA 018340) 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 A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.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 Aerobid have a generic?

Yes. The Orange Book lists 4 approved generic (ANDA) applications sharing Aerobid's active ingredient (Flunisolide). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

What is Aerobid's FDA application number?

Aerobid is approved under NDA 018340, held by Roche Palo.

Orange Book product · Brand (NDA)

Aerobid

Flunisolide

Brand (NDA)NDA 018340Discontinued Roche Palo

Approved

Aug 17, 1984

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aerobid (Flunisolide) is Roche Palo's brand-name drug, approved by the FDA under NDA 018340 in 1984. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 4 approved generics share this drug's active ingredient.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.
Aug 17, 1984
42 yr 6 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

FLUNISOLIDE

Strength

0.25MG/INH

Dosage form

AEROSOL, METERED

Route

INHALATION

TE code

Not listed

Application

NDA 018340

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Flunisolide 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.

Aerobid — 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 Flunisolide active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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