Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nitisinone
Product Details
NDC Product Code
63629-2234Application Number
ANDA211041Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
November 12, 2019NitisinoneActive
Code: K5BN214699Class: ACTIBQuantity: 2 mg in 1 1
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4Class: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT