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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215932


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NDA 215932 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 215932
Tradename:GUAIFENESIN
Applicant:Dr Reddys
Ingredient:guaifenesin
Patents:0
Pharmacology for NDA: 215932
Medical Subject Heading (MeSH) Categories for 215932
Suppliers and Packaging for NDA: 215932
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 215932 ANDA Dr. Reddy's Laboratories Inc. 43598-008 43598-008-01 5 BLISTER PACK in 1 CARTON (43598-008-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)
GUAIFENESIN guaifenesin TABLET, EXTENDED RELEASE;ORAL 215932 ANDA Dr. Reddy's Laboratories Inc. 43598-008 43598-008-40 2 BLISTER PACK in 1 CARTON (43598-008-40) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (43598-008-20)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG
Approval Date:Mar 15, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM
Approval Date:Mar 15, 2022TE:RLD:No

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