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Serving leading biopharmaceutical companies globally:

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Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090444

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NDA 090444 describes IMIPRAMINE PAMOATE, which is a drug marketed by Lupin Ltd, Mylan Pharms Inc, and West-ward Pharms Int, and is included in three NDAs. It is available from four suppliers. Additional details are available on the IMIPRAMINE PAMOATE profile page.

The generic ingredient in IMIPRAMINE PAMOATE is imipramine pamoate. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the imipramine pamoate profile page.
Summary for 090444
Applicant:Lupin Ltd
Ingredient:imipramine pamoate
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 090444
Suppliers and Packaging for NDA: 090444
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 090444 ANDA LUPIN LIMITED 57297-314 E 57297-314-01
IMIPRAMINE PAMOATE imipramine pamoate CAPSULE;ORAL 090444 ANDA LUPIN LIMITED 57297-314 E 57297-314-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG HCL
Approval Date:Apr 16, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG HCL
Approval Date:Apr 16, 2010TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 125MG HCL
Approval Date:Apr 16, 2010TE:ABRLD:No

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Queensland Health
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