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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 078912


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NDA 078912 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-eight 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-one suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.
Summary for 078912
Tradename:GUAIFENESIN
Applicant:Perrigo R And D
Ingredient:guaifenesin
Patents:0
Pharmacology for NDA: 078912
Medical Subject Heading (MeSH) Categories for 078912
Suppliers and Packaging for NDA: 078912
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912 ANDA L. Perrigo Company 0113-2023 0113-2023-60 1 BOTTLE in 1 CARTON (0113-2023-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 078912 ANDA Target Corporation 11673-421 11673-421-60 1 BOTTLE in 1 CARTON (11673-421-60) / 20 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Nov 23, 2011TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Nov 5, 2020TE:RLD:No

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