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Details for New Drug Application (NDA): 075706

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NDA 075706 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-six 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-seven suppliers are listed for this compound. Additional details are available on the loratadine; pseudoephedrine sulfate profile page.

Summary for NDA: 075706

Tradename:
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Applicant:
Actavis Labs Fl Inc
Ingredient:
loratadine; pseudoephedrine sulfate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 075706

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 075706 ANDA L Perrigo Company 0113-1165 0113-1165-22 3 BLISTER PACK in 1 CARTON (0113-1165-22) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL 075706 ANDA L Perrigo Company 0113-1165 0113-1165-52 2 BLISTER PACK in 1 CARTON (0113-1165-52) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG;240MG
Approval Date:Feb 21, 2003TE:RLD:No


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