Loxapine

Loxapine capsules A072062 A072204 A072205 A072206

Approved

Approval ID

a6107bb1-3e23-4c5d-bbf4-5e29deff6728

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 30, 2016

Manufacturers

FDA

Actavis Pharma, Inc.

DUNS: 119723554

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0591-0369

Application NumberANDA072204

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 30, 2016

FDA Product Classification

INGREDIENTS (19)

LOXAPINE SUCCINATEActive

Quantity: 5 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

BUTYLPARABENInactive

Code: 3QPI1U3FV8

Classification: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBH

Classification: IACT

EDETATE CALCIUM DISODIUMInactive

Code: 25IH6R4SGF

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OH

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

SODIUM PROPIONATEInactive

Code: DK6Y9P42IN

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0591-0372

Application NumberANDA072062

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 30, 2016

FDA Product Classification

INGREDIENTS (20)

LOXAPINE SUCCINATEActive

Quantity: 50 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

BENZYL ALCOHOLInactive

Code: LKG8494WBH

Classification: IACT

BUTYLPARABENInactive

Code: 3QPI1U3FV8

Classification: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

EDETATE CALCIUM DISODIUMInactive

Code: 25IH6R4SGF

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

SODIUM PROPIONATEInactive

Code: DK6Y9P42IN

Classification: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OH

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0591-0371

Application NumberANDA072206

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 30, 2016

FDA Product Classification

INGREDIENTS (21)

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

BUTYLPARABENInactive

Code: 3QPI1U3FV8

Classification: IACT

EDETATE CALCIUM DISODIUMInactive

Code: 25IH6R4SGF

Classification: IACT

LOXAPINE SUCCINATEActive

Quantity: 25 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

BENZYL ALCOHOLInactive

Code: LKG8494WBH

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OH

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SODIUM PROPIONATEInactive

Code: DK6Y9P42IN

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC PHOSPHATEInactive

Code: 91GQH8I5F7

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

Loxapine

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0591-0370

Application NumberANDA072205

Product Classification

Marketing Category

C73584

Generic Name

Loxapine

Product Specifications

Route of AdministrationORAL

Effective DateDecember 30, 2016

FDA Product Classification

INGREDIENTS (21)

LOXAPINE SUCCINATEActive

Quantity: 10 mg in 1 1

Code: X59SG0MRYU

Classification: ACTIM

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

BENZYL ALCOHOLInactive

Code: LKG8494WBH

Classification: IACT

METHYLPARABENInactive

Code: A2I8C7HI9T

Classification: IACT

BUTYLPARABENInactive

Code: 3QPI1U3FV8

Classification: IACT

EDETATE CALCIUM DISODIUMInactive

Code: 25IH6R4SGF

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

POLACRILIN POTASSIUMInactive

Code: 0BZ5A00FQU

Classification: IACT

PROPYLPARABENInactive

Code: Z8IX2SC1OH

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SODIUM PROPIONATEInactive

Code: DK6Y9P42IN

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

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Loxapine

Products 4

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (19)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (20)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

Loxapine

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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