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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214407


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NDA 214407 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl, Aurobindo Pharma Ltd, Dr Reddys, Granules, L Perrigo Co, and Sun Pharm Inds Inc, and is included in six NDAs. It is available from twenty-seven suppliers. Additional details are available on the GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE 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.
Pharmacology for NDA: 214407
Suppliers and Packaging for NDA: 214407
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214407 ANDA Walgreen Company 0363-2389 0363-2389-62 4 BLISTER PACK in 1 CARTON (0363-2389-62) / 6 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE guaifenesin; pseudoephedrine hydrochloride TABLET, EXTENDED RELEASE;ORAL 214407 ANDA Walgreen Company 0363-8708 0363-8708-68 2 BLISTER PACK in 1 CARTON (0363-8708-68) / 18 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:Feb 1, 2022TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM;120MG
Approval Date:Feb 1, 2022TE:RLD:No

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