Details for New Drug Application (NDA): 213087
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NDA 213087 describes FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, which is a drug marketed by Cipla, Hikma, Respirent Pharms, and Teva Pharms Usa, and is included in four NDAs. It is available from six suppliers. Additional details are available on the FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE profile page.
The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is fluticasone propionate; salmeterol xinafoate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE is fluticasone propionate; salmeterol xinafoate. There is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 213087
| Tradename: | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
| Applicant: | Cipla |
| Ingredient: | fluticasone propionate; salmeterol xinafoate |
| Patents: | 0 |
Pharmacology for NDA: 213087
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 213087
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 213087 | ANDA | Cipla USA Inc. | 69097-661 | 69097-661-03 | 1 INHALER in 1 CARTON (69097-661-03) / 60 POWDER in 1 INHALER |
| FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 213087 | ANDA | Cipla USA Inc. | 69097-662 | 69097-662-03 | 1 INHALER in 1 CARTON (69097-662-03) / 60 POWDER in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Jul 27, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.25MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Jul 27, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.5MG/INH;EQ 0.05MG BASE/INH | ||||
| Approval Date: | Jul 27, 2026 | TE: | AB | RLD: | No | ||||
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