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Details for New Drug Application (NDA): 075520

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NDA 075520 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Pharm Assoc, Taro, Teva, Mylan, Aurolife Pharma Llc, Mayne Pharma, and Idt Australia Ltd, and is included in twelve NDAs. It is available from thirty-two suppliers. Additional details are available on the NORTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are ten drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

Summary for NDA: 075520

nortriptyline hydrochloride
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 075520

Suppliers and Packaging for NDA: 075520

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nortriptyline hydrochloride
CAPSULE;ORAL 075520 ANDA Medsource Pharmaceuticals 45865-729 45865-729-30 30 CAPSULE in 1 BOTTLE (45865-729-30)
nortriptyline hydrochloride
CAPSULE;ORAL 075520 ANDA A-S Medication Solutions 50090-0507 50090-0507-0 30 CAPSULE in 1 BOTTLE (50090-0507-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 8, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:May 8, 2000TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:May 8, 2000TE:ABRLD:No

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