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Details for New Drug Application (NDA): 086941

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NDA 086941 describes CHLORPHENIRAMINE MALEATE, which is a drug marketed by Sun Pharm Inds, Pharmavite, Purepac Pharm, Impax Labs, Newtron Pharms, Pharm Assoc, Bel Mar, Roxane, Avanthi Inc, Vitarine, Elkins Sinn, Watson Labs, Lederle, Panray, Pharmeral, Pioneer Pharms, Aurolife Pharma Llc, Bell Pharma, Kv Pharm, Anabolic, Ivax Sub Teva Pharms, Pvt Form, and West Ward, and is included in thirty NDAs. It is available from three 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. Four suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

Summary for NDA: 086941

Tradename:
CHLORPHENIRAMINE MALEATE
Applicant:
Lederle
Ingredient:
chlorpheniramine maleate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No


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