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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210453


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NDA 210453 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 seventy-nine 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. Thirty suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 210453
Tradename:GUAIFENESIN
Applicant:Aurobindo Pharma
Ingredient:guaifenesin
Patents:0
Pharmacology for NDA: 210453
Medical Subject Heading (MeSH) Categories for 210453
Suppliers and Packaging for NDA: 210453
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 210453 ANDA WALGREEN CO. 0363-0033 0363-0033-01 1 BLISTER PACK in 1 CARTON (0363-0033-01) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 210453 ANDA WALGREEN CO. 0363-0033 0363-0033-02 2 BLISTER PACK in 1 CARTON (0363-0033-02) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Oct 21, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Oct 21, 2019TE:RLD:No

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