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Last Updated: July 24, 2024

Details for New Drug Application (NDA): 076868


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NDA 076868 describes LOXAPINE SUCCINATE, which is a drug marketed by Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the LOXAPINE SUCCINATE profile page.

The generic ingredient in LOXAPINE SUCCINATE is loxapine succinate. There are eight drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the loxapine succinate profile page.
Summary for 076868
Tradename:LOXAPINE SUCCINATE
Applicant:Elite Labs Inc
Ingredient:loxapine succinate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076868 ANDA Burel Pharmaceuticals, LLC 35573-436 35573-436-02 100 CAPSULE in 1 BOTTLE (35573-436-02)
LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 076868 ANDA Burel Pharmaceuticals, LLC 35573-437 35573-437-02 100 CAPSULE in 1 BOTTLE (35573-437-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Aug 4, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Aug 4, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Aug 4, 2005TE:ABRLD:No

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