Is Advair Diskus 500/50 still available?

Yes. Advair Diskus 500/50 (NDA 021077) is listed with marketing status Prescription in the FDA Orange Book.

What does Advair Diskus 500/50's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Advair Diskus 500/50 substitutable for its reference brand with no expected difference in clinical effect.

What is Advair Diskus 500/50's FDA application number?

Advair Diskus 500/50 is approved under NDA 021077, held by Glaxo Grp Ltd.

Orange Book product · Brand (NDA)

Advair Diskus 500/50

Fluticasone Propionate; Salmeterol Xinafoate

Brand (NDA)NDA 021077TE ABRLD Glaxo Grp Ltd

Approved

Aug 24, 2000

Application

Brand (NDA)

TE code

Listed patents

Advair Diskus 500/50 (Fluticasone Propionate; Salmeterol Xinafoate) is Glaxo Grp Ltd's brand-name drug, approved by the FDA under NDA 021077 in 2000. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand. 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 24, 2000
26 yr 3 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Dosage form

POWDER

Route

INHALATION

TE code

Application

NDA 021077

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Same application

Other strengths in NDA 021077

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 Fluticasone Propionate; Salmeterol Xinafoate 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.