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Details for New Drug Application (NDA): 091071

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NDA 091071 describes GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc and is included in one NDA. It is available from fifteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the guaifenesin; pseudoephedrine hydrochloride profile page.

Summary for NDA: 091071

Suppliers and Packaging for NDA: 091071

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 091071 ANDA L. Perrigo Company 0113-0144 0113-0144-89 18 BLISTER PACK in 1 CARTON (0113-0144-89) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
guaifenesin; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL 091071 ANDA L. Perrigo Company 0113-2002 0113-2002-68 36 BLISTER PACK in 1 CARTON (0113-2002-68) > 1 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength600MG;60MG
Approval Date:May 27, 2015TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength1.2GM;120MG
Approval Date:May 27, 2015TE:RLD:No


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