Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Par Pharmaceutical Inc.
092733690
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
49884-549Application Number
NDA020547Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 25, 2022ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
Zafirlukast
Product Details
NDC Product Code
49884-554Application Number
NDA020547Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
October 25, 2022ZafirlukastActive
Code: XZ629S5L50Class: ACTIBQuantity: 20 mg in 1 1
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98GClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT