Medicine
Azelastine and Fluticasone propionate 137 mcg/50 mcg nasal spray
Azelastine and Fluticasone propionate 137 mcg/50 mcg nasal spray is a generic prescription medicine for nasal use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Do not store in the freezer or refrigerator. Store upright with the dust cap…
Key facts
- Active ingredient (INN)
- Azelastine and Fluticasone propionate
- Brand
- Sold under the generic name
- Strength
- 137 mcg/50 mcg
- Dosage form
- Nasal spray
- Route
- Nasal
- Packs
- 1 bottle and 3 more
- Manufacturers
- Bryant Ranch PrepackApotexMylan PharmaceuticalsPadagis Israel PharmaceuticalsTeva Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Do not store in the freezer or refrigerator. Store upright with the dust cap in place at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 2 March 2020
- Identifiers
- RxCUI 1797847DailyMed set ID 1a930a09-db26-40aa-bb05-123a0d7182bc, 0d45e7a4-900f-44ef-bb18-a1fbff75a3c6, 7b5cc5a0-0d47-46b5-b5fb-eb9cc248ae9e +3NDC 63629-8612, 0480-2157, 0378-3458 +3Application ANDA208111, ANDA208436, NDA202236 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray | 60505-0953-3 | Apotex | 2 March 2020 |
| 1 bottle in 1 box / 120 spray, metered in 1 bottle | 0378-3458-23 | Mylan Pharmaceuticals | 14 April 2020 |
| 1 bottle in 1 carton / 120 spray, metered in 1 bottle | 45802-066-01 | Padagis Israel Pharmaceuticals | 1 March 2021 |
| 1 bottle, spray in 1 carton / 120 spray, metered in 1 bottle, spray | 0480-2157-57 | Teva Pharmaceuticals | 8 September 2025 |
| 1 bottle in 1 carton / 120 spray, metered in 1 bottle | 63629-8612-1 | Bryant Ranch Prepack | 1 March 2021 |
| 1 bottle in 1 carton / 120 spray, metered in 1 bottle | 72162-1388-2 | Bryant Ranch Prepack | 8 February 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 1 May 2012 | 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 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Azelastine and Fluticasone propionate 137 mcg/50 mcg nasal spray.
Clinical summary
Azelastine and Fluticasone propionate is a fixed-dose combination of a corticosteroid and a histamine-1 receptor antagonist indicated for the relief of symptoms of seasonal allergic rhinitis in adult, among other approved uses. MedsAcross supplies Azelastine and Fluticasone propionate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Azelastine and Fluticasone propionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Azelastine Hydrochloride and Fluticasone Propionate prescribing information (Mylan Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Azelastine and Fluticasone propionate 137 mcg/50 mcg nasal spray for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.