Details for New Drug Application (NDA): 203433
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The generic ingredient in FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE 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 203433
Tradename: | FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE |
Applicant: | Hikma |
Ingredient: | fluticasone propionate; salmeterol xinafoate |
Patents: | 0 |
Pharmacology for NDA: 203433
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 203433
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 | 203433 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0326 | 0054-0326-56 | 1 POUCH in 1 CARTON (0054-0326-56) / 1 INHALER in 1 POUCH / 60 POWDER in 1 INHALER |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE | fluticasone propionate; salmeterol xinafoate | POWDER;INHALATION | 203433 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0327 | 0054-0327-56 | 1 POUCH in 1 CARTON (0054-0327-56) / 1 INHALER in 1 POUCH / 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: | Dec 17, 2020 | 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: | Dec 17, 2020 | 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: | Dec 19, 2023 | TE: | AB | RLD: | No |
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