Details for New Drug Application (NDA): 208799
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NDA 208799 describes AIRDUO RESPICLICK, which is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are sixteen patents protecting this drug. Additional details are available on the AIRDUO RESPICLICK profile page.
The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 208799
| Tradename: | AIRDUO RESPICLICK |
| Applicant: | Teva Pharm |
| Ingredient: | fluticasone propionate; salmeterol xinafoate |
| Patents: | 28 |
Pharmacology for NDA: 208799
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 208799
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3607 | 0093-3607-82 | 1 POUCH in 1 CARTON (0093-3607-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
| AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799 | NDA AUTHORIZED GENERIC | Teva Pharmaceuticals USA, Inc. | 0093-3607 | 0093-3607-82 | 1 POUCH in 1 CARTON (0093-3607-82) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.055MG/INH;EQ 0.014MG BASE/INH | ||||
| Approval Date: | Jan 27, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 9, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 9, 2024 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Nov 18, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 208799
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-006 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | AIRDUO DIGIHALER | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-004 | Jul 12, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Teva Pharm | AIRDUO RESPICLICK | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 208799-001 | Jan 27, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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