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Details for New Drug Application (NDA): 077153

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NDA 077153 describes LORATADINE REDIDOSE, which is a drug marketed by Sun Pharm Inds Ltd and is included in one NDA. It is available from twenty-two suppliers. Additional details are available on the LORATADINE REDIDOSE profile page.

The generic ingredient in LORATADINE REDIDOSE is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and twenty-four suppliers are listed for this compound. Additional details are available on the loratadine profile page.

Summary for NDA: 077153

Tradename:
LORATADINE REDIDOSE
Applicant:
Sun Pharm Inds Ltd
Ingredient:
loratadine
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077153

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LORATADINE REDIDOSE
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL 077153 ANDA Walgreen Company 0363-0527 0363-0527-31 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0363-0527-31)
LORATADINE REDIDOSE
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL 077153 ANDA Walgreen Company 0363-0527 0363-0527-69 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0363-0527-69)

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Apr 11, 2007TE:RLD:No


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