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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 209215


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NDA 209215 describes GUAIFENESIN, which is a drug marketed by Actavis Labs Fl, Amneal Pharms, Aurobindo Pharma, Dr Reddys, Granules, Guardian Drug, Marksans Pharma, Ohm Labs Inc, Perrigo R And D, Sun Pharm, Aurobindo Pharma Ltd, L Perrigo Co, and Sun Pharm Inds Inc, and is included in twenty-one NDAs. It is available from eighty-six suppliers. Additional details are available on the GUAIFENESIN profile page.

The generic ingredient in GUAIFENESIN is guaifenesin; pseudoephedrine hydrochloride. There are twenty drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 209215
Tradename:GUAIFENESIN
Applicant:Guardian Drug
Ingredient:guaifenesin
Patents:0
Pharmacology for NDA: 209215
Physiological EffectDecreased Respiratory Secretion Viscosity
Increased Respiratory Secretions
Medical Subject Heading (MeSH) Categories for 209215
Expectorants
Suppliers and Packaging for NDA: 209215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209215 ANDA Major Pharmaceuticals 0904-6986 0904-6986-40 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0904-6986-40)
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 209215 ANDA Topco Associates, LLC 36800-226 36800-226-16 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (36800-226-16)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Sep 6, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Sep 6, 2017TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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