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Details for New Drug Application (NDA): 090444

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NDA 090444 describes IMIPRAMINE PAMOATE, which is a drug marketed by Mylan Pharms Inc, Lupin Ltd, and West-ward Pharms Int, and is included in three NDAs. It is available from three 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 NDA: 090444

Lupin Ltd
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
CAPSULE;ORAL 090444 ANDA LUPIN LIMITED 57297-314 57297-314-01 100 CAPSULE in 1 BOTTLE (57297-314-01)
imipramine pamoate
CAPSULE;ORAL 090444 ANDA LUPIN LIMITED 57297-314 57297-314-06 30 CAPSULE in 1 BOTTLE (57297-314-06)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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