EMFLAZA
These highlights do not include all the information needed to use EMFLAZA safely and effectively. See full prescribing information for EMFLAZA. EMFLAZA (deflazacort) tablets, for oral use EMFLAZA (deflazacort) oral suspension Initial U.S. Approval: 2017
Approved
Approval ID
31b347d2-f156-4055-9d8f-7cf0df420296
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 21, 2023
Manufacturers
FDA
PTC Therapeutics, Inc.
DUNS: 124371951
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
deflazacort
PRODUCT DETAILS
NDC Product Code52856-504
Application NumberNDA208684
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 6, 2021
Generic Namedeflazacort
INGREDIENTS (5)
DEFLAZACORTActive
Quantity: 36 mg in 1 1
Code: KR5YZ6AE4B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
deflazacort
PRODUCT DETAILS
NDC Product Code52856-502
Application NumberNDA208684
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 6, 2021
Generic Namedeflazacort
INGREDIENTS (5)
DEFLAZACORTActive
Quantity: 18 mg in 1 1
Code: KR5YZ6AE4B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
deflazacort
PRODUCT DETAILS
NDC Product Code52856-503
Application NumberNDA208684
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 6, 2021
Generic Namedeflazacort
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DEFLAZACORTActive
Quantity: 30 mg in 1 1
Code: KR5YZ6AE4B
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
deflazacort
PRODUCT DETAILS
NDC Product Code52856-505
Application NumberNDA208685
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 6, 2021
Generic Namedeflazacort
INGREDIENTS (8)
DEFLAZACORTActive
Quantity: 22.75 mg in 1 mL
Code: KR5YZ6AE4B
Classification: ACTIB
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
deflazacort
PRODUCT DETAILS
NDC Product Code52856-501
Application NumberNDA208684
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 6, 2021
Generic Namedeflazacort
INGREDIENTS (5)
DEFLAZACORTActive
Quantity: 6 mg in 1 1
Code: KR5YZ6AE4B
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT