Fixed-dose combination
Budesonide, Formoterol and Glycopyrrolate
- Presentations
- 2
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Budesonide, Formoterol and Glycopyrrolate is a anticholinergic. MedsAcross lists 2 presentations of it from 1 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Anticholinergic, Beta2-Adrenergic Agonist, Cholinergic Muscarinic Antagonist, Corticosteroid, Adrenergic beta2-Agonists, Cholinergic Antagonists, Cholinergic Muscarinic Antagonists, Corticosteroid Hormone Receptor Agonists
- US FDA first approval
- 23 July 2020
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Inhalation
- Dosage forms
- Inhaler
- Fixed-dose combination of
- Budesonide, Formoterol, Glycopyrrolate
All presentations
2 presentations of Budesonide, Formoterol and Glycopyrrolate, sorted by availability.
| Medicine | Active ingredient | Manufacturer | Register | Availability |
|---|---|---|---|---|
| Breztri 160 mcg/4.8 mcg/18 mcg inhalerInhalation | Budesonide, Formoterol and Glycopyrrolate | AstraZeneca Pharmaceuticals | US FDA | Available on request |
| Breztri 160 mcg/4.8 mcg/9 mcg inhalerInhalation | Budesonide, Formoterol and Glycopyrrolate | AstraZeneca Pharmaceuticals | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 23 July 2020 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Budesonide, Formoterol and Glycopyrrolate available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Budesonide, Formoterol and Glycopyrrolate and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Budesonide, Formoterol and Glycopyrrolate have?
The catalogue lists 1 brand names for Budesonide, Formoterol and Glycopyrrolate, including Breztri.
Is Budesonide, Formoterol and Glycopyrrolate approved by the US FDA?
Yes. The US FDA first approved Budesonide, Formoterol and Glycopyrrolate on 23 July 2020, according to Drugs@FDA.
Does Budesonide, Formoterol and Glycopyrrolate need cold chain shipping?
No listed presentation of Budesonide, Formoterol and Glycopyrrolate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Request Budesonide, Formoterol and Glycopyrrolate for export supply
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.