Loxapine

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Elite Laboratories, Inc.

DUNS Number

785398728

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Elite Laboratories, Inc.

Labeler

Elite Laboratories, Inc.

Registrant

Elite Laboratories, Inc.

DUNS Number

785398728

Products4

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

Product Details

NDC Product Code

64850-892

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2022

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 25 mg in 1 1

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Loxapine

Product Details

NDC Product Code

64850-891

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2022

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 10 mg in 1 1

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Loxapine

Product Details

NDC Product Code

64850-893

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2022

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 50 mg in 1 1

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Loxapine

Product Details

NDC Product Code

64850-890

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 20, 2022

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 5 mg in 1 1

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

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Loxapine

FDA Approval Summary

Registrants1

Manufacturing Establishments1

Products4

Loxapine

Product Details

Loxapine

Product Details

Loxapine

Product Details

Loxapine

Product Details