Details for New Drug Application (NDA): 208798
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NDA 208798 describes ARMONAIR RESPICLICK, which is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ARMONAIR RESPICLICK profile page.
The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-five suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 208798
| Tradename: | ARMONAIR RESPICLICK |
| Applicant: | Teva Pharm |
| Ingredient: | fluticasone propionate |
| Patents: | 25 |
Pharmacology for NDA: 208798
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208798
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798 | NDA | Teva Respiratory, LLC | 59310-200 | 59310-200-06 | 1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798 | NDA | Teva Respiratory, LLC | 59310-200 | 59310-200-06 | 1 POUCH in 1 CARTON (59310-200-06) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INHALATION | Strength | 0.055MG/INH | ||||
| Approval Date: | Jan 27, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 9, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jan 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 18, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208798
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-001 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-006 | Feb 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR DIGIHALER | fluticasone propionate | POWDER;INHALATION | 208798-004 | Feb 20, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-002 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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