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Generated: November 13, 2018

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Details for New Drug Application (NDA): 019906

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NDA 019906 describes ANAFRANIL, which is a drug marketed by Specgx Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ANAFRANIL profile page.

The generic ingredient in ANAFRANIL is clomipramine hydrochloride. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the clomipramine hydrochloride profile page.
Summary for 019906
Tradename:ANAFRANIL
Applicant:Specgx Llc
Ingredient:clomipramine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019906
Medical Subject Heading (MeSH) Categories for 019906
Suppliers and Packaging for NDA: 019906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANAFRANIL clomipramine hydrochloride CAPSULE;ORAL 019906 NDA SpecGx LLC 0406-8806 0406-8806-01 100 CAPSULE in 1 BOTTLE (0406-8806-01)
ANAFRANIL clomipramine hydrochloride CAPSULE;ORAL 019906 NDA SpecGx LLC 0406-8807 0406-8807-01 100 CAPSULE in 1 BOTTLE (0406-8807-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 29, 1989TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 29, 1989TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG
Approval Date:Dec 29, 1989TE:ABRLD:Yes

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