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

Burel Pharmaceuticals, LLC

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

35573-437

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 10 mg in 1 1

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: 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. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

Loxapine

Product Details

NDC Product Code

35573-439

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: IACT

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 50 mg in 1 1

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: 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

Loxapine

Product Details

NDC Product Code

35573-436

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: 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

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 5 mg in 1 1

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

Loxapine

Product Details

NDC Product Code

35573-438

Application Number

ANDA076868

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 7, 2021

Ingredients

LoxapineActive

Code: X59SG0MRYUClass: ACTIMQuantity: 25 mg in 1 1

Silicon DioxideInactive

Code: ETJ7Z6XBU4Class: IACT

Hypromellose, UnspecifiedInactive

Code: 3NXW29V3WOClass: IACT

Lactose MonohydrateInactive

Code: EWQ57Q8I5XClass: IACT

Titanium DioxideInactive

Code: 15FIX9V2JPClass: IACT

Magnesium StearateInactive

Code: 70097M6I30Class: IACT

Butyl AlcoholInactive

Code: 8PJ61P6TS3Class: IACT

ShellacInactive

Code: 46N107B71OClass: IACT

Ferrosoferric OxideInactive

Code: XM0M87F357Class: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3Class: IACT

Fd&C Blue No. 2--Aluminum LakeInactive

Code: 4AQJ3LG584Class: IACT

D&C Yellow No. 10Inactive

Code: 35SW5USQ3GClass: IACT

Fd&C Blue No. 1Inactive

Code: H3R47K3TBDClass: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JMClass: IACT

Ferric Oxide YellowInactive

Code: EX438O2MRTClass: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOAClass: 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