Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Annora Pharma Private Limited
Camber Pharmaceuticals, Inc.
650980746
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zafirlukast
Product Details
NDC Product Code
31722-008Application Number
ANDA212475Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 17, 2020ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 20 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
Zafirlukast
Product Details
NDC Product Code
31722-007Application Number
ANDA212475Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 17, 2020ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 10 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT