Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loxapine
Product Details
NDC Product Code
82804-051Application Number
ANDA090695Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 1, 2023LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT