Details for New Drug Application (NDA): 208798
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The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two 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: | 6 |
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: | 10,195,375*PED | Patent Expiration: | Aug 14, 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 | 8,006,690 | ⤷ Get Started Free |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-003 | Jan 27, 2017 | 6,701,917 | ⤷ Get Started Free |
| Teva Pharm | ARMONAIR RESPICLICK | fluticasone propionate | POWDER;INHALATION | 208798-001 | Jan 27, 2017 | 6,871,646 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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