Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
West-Ward Columbus Inc.
Hikma Pharmaceuticals USA Inc.
058839929
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluticasone propionate and salmeterol
Product Details
NDC Product Code
0054-0326Application Number
ANDA203433Marketing Category
ANDA (C73584)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 19, 2023SalmeterolActive
Code: 6EW8Q962A5Class: ACTIMQuantity: 50 ug in 1 1
Fluticasone propionateActive
Code: O2GMZ0LF5WClass: ACTIBQuantity: 100 ug in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
fluticasone propionate and salmeterol
Product Details
NDC Product Code
0054-0327Application Number
ANDA203433Marketing Category
ANDA (C73584)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 19, 2023LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SalmeterolActive
Code: 6EW8Q962A5Class: ACTIMQuantity: 50 ug in 1 1
Fluticasone propionateActive
Code: O2GMZ0LF5WClass: ACTIBQuantity: 250 ug in 1 1
fluticasone propionate and salmeterol
Product Details
NDC Product Code
0054-0328Application Number
ANDA203433Marketing Category
ANDA (C73584)Route of Administration
RESPIRATORY (INHALATION)Effective Date
December 19, 2023Fluticasone propionateActive
Code: O2GMZ0LF5WClass: ACTIBQuantity: 500 ug in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
SalmeterolActive
Code: 6EW8Q962A5Class: ACTIMQuantity: 50 ug in 1 1