Accolate
ACCOLATE® () TABLETS
Approved
Approval ID
d31ecca3-23ff-470e-8c91-1bea8a537b3c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2015
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zafirlukast
PRODUCT DETAILS
NDC Product Code49884-590
Application NumberNDA020547
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2022
Generic Namezafirlukast
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
zafirlukast
PRODUCT DETAILS
NDC Product Code49884-589
Application NumberNDA020547
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateSeptember 28, 2022
Generic Namezafirlukast
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 10 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT