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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
Chartwell RX, LLC
DUNS: 079394054
Effective Date
March 1, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Loxapine(5 mg in 1 1)

Products2

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
62135-492
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 1, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 5 mg in 1 1

Loxapine

Product Details

NDC Product Code
62135-493
Application Number
ANDA090695
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 1, 2023
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQUClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NHClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
LoxapineActive
Code: X59SG0MRYUClass: ACTIMQuantity: 10 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15Class: IACT
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