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Details for New Drug Application (NDA): 016792

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NDA 016792 describes SURMONTIL, which is a drug marketed by Odyssey Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the SURMONTIL profile page.

The generic ingredient in SURMONTIL is trimipramine maleate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the trimipramine maleate profile page.

Summary for NDA: 016792

Tradename:
SURMONTIL
Applicant:
Odyssey Pharms
Ingredient:
trimipramine maleate
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 016792

Suppliers and Packaging for NDA: 016792

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SURMONTIL
trimipramine maleate
CAPSULE;ORAL 016792 NDA Teva Women's Health, Inc. 51285-538 51285-538-02 100 CAPSULE in 1 BOTTLE (51285-538-02)
SURMONTIL
trimipramine maleate
CAPSULE;ORAL 016792 NDA Teva Women's Health, Inc. 51285-539 51285-539-02 100 CAPSULE in 1 BOTTLE (51285-539-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Sep 15, 1982TE:ABRLD:No


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