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Generated: September 19, 2018

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Details for New Drug Application (NDA): 076050

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NDA 076050 describes LORATADINE AND PSEUDOEPHEDRINE SULFATE, which is a drug marketed by Actavis Labs Fl Inc, Perrigo Pharma Intl, and Sun Pharm Inds Ltd, and is included in five NDAs. It is available from forty-three suppliers. Additional details are available on the LORATADINE AND PSEUDOEPHEDRINE SULFATE profile page.

The generic ingredient in LORATADINE AND PSEUDOEPHEDRINE SULFATE is loratadine; pseudoephedrine sulfate. There are thirty-nine drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.
Summary for 076050
Pharmacology for NDA: 076050
Mechanism of ActionAdrenergic alpha-Agonists
Suppliers and Packaging for NDA: 076050
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076050 ANDA L. Perrigo Company 0113-2007 0113-2007-46 10 BLISTER PACK in 1 CARTON (0113-2007-46) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
LORATADINE AND PSEUDOEPHEDRINE SULFATE loratadine; pseudoephedrine sulfate TABLET, EXTENDED RELEASE;ORAL 076050 ANDA L. Perrigo Company 0113-2007 0113-2007-60 20 BLISTER PACK in 1 CARTON (0113-2007-60) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Jan 30, 2003TE:RLD:No

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