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Generated: December 19, 2018

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Details for New Drug Application (NDA): 075606

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NDA 075606 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Aurolife Pharma Llc, Mayne Pharma, Mylan, Taro Pharm, Teva, Pharm Assoc, and Taro, and is included in nine NDAs. It is available from twenty-six suppliers. Additional details are available on the NORTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are eleven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.
Summary for 075606
Applicant:Pharm Assoc
Ingredient:nortriptyline hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 075606
Medical Subject Heading (MeSH) Categories for 075606
Suppliers and Packaging for NDA: 075606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride SOLUTION;ORAL 075606 ANDA Pharmaceutical Associates, Inc. 0121-0678 0121-0678-16 473 mL in 1 BOTTLE (0121-0678-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrengthEQ 10MG BASE/5ML
Approval Date:Aug 28, 2000TE:AARLD:No

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