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Details for New Drug Application (NDA): 090695

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NDA 090695 describes LOXAPINE SUCCINATE, which is a drug marketed by Watson Labs, Mylan, Elite Labs Inc, and Lannett Holdings Inc, and is included in seven NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the loxapine succinate profile page.

Summary for NDA: 090695

Tradename:
LOXAPINE SUCCINATE
Applicant:
Lannett Holdings Inc
Ingredient:
loxapine succinate
Patents:0
Therapeutic Class:Antipsychotics
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 090695

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL 090695 ANDA Lannett Company, Inc. 0527-1394 0527-1394-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1394-01)
LOXAPINE SUCCINATE
loxapine succinate
CAPSULE;ORAL 090695 ANDA Lannett Company, Inc. 0527-1394 0527-1394-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0527-1394-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE
Approval Date:Sep 26, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Sep 26, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Sep 26, 2011TE:ABRLD:No


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