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Last Updated: August 11, 2020

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Details for New Drug Application (NDA): 040829

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NDA 040829 describes CHLORPHENIRAMINE MALEATE, which is a drug marketed by Aurolife Pharma Llc, Bel Mar, Elkins Sinn, Watson Labs, Pharm Assoc, Avanthi Inc, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, and West Ward, and is included in thirty NDAs. It is available from two suppliers. Additional details are available on the CHLORPHENIRAMINE MALEATE profile page.

The generic ingredient in CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.
Summary for 040829
Tradename:CHLORPHENIRAMINE MALEATE
Applicant:Avanthi Inc
Ingredient:chlorpheniramine maleate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040829
Suppliers and Packaging for NDA: 040829
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET, EXTENDED RELEASE;ORAL 040829 ANDA KVK-Tech, Inc. 10702-017 10702-017-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-01)
CHLORPHENIRAMINE MALEATE chlorpheniramine maleate TABLET, EXTENDED RELEASE;ORAL 040829 ANDA KVK-Tech, Inc. 10702-017 10702-017-06 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-017-06)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength12MG
Approval Date:May 13, 2009TE:RLD:No

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