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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 072204

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NDA 072204 describes LOXAPINE SUCCINATE, which is a drug marketed by Elite Labs Inc, Lannett Co Inc, Mylan, and Watson Labs, and is included in seven NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the loxapine succinate profile page.
Summary for 072204
Applicant:Watson Labs
Ingredient:loxapine succinate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 072204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072204 ANDA Actavis Pharma, Inc. 0591-0369 0591-0369-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-0369-01)
LOXAPINE SUCCINATE loxapine succinate CAPSULE;ORAL 072204 ANDA REMEDYREPACK INC. 70518-0346 70518-0346-0 30 CAPSULE in 1 BLISTER PACK (70518-0346-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Jun 15, 1988TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Boehringer Ingelheim

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