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FDA Approval

Loxapine

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 9, 2016
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Loxapine(5 mg in 1 1)

Products4

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
10135-585
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 10, 2016
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 5 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT

Loxapine

Product Details

NDC Product Code
10135-588
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 10, 2016
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 50 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT

Loxapine

Product Details

NDC Product Code
10135-586
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 10, 2016
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 10 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT

Loxapine

Product Details

NDC Product Code
10135-587
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
February 10, 2016
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 25 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
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