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Generated: January 23, 2019

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Details for New Drug Application (NDA): 021375

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NDA 021375 describes ALAVERT, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the ALAVERT profile page.

The generic ingredient in ALAVERT is loratadine. There are thirty-nine drug master file entries for this compound. One hundred and forty-six suppliers are listed for this compound. Additional details are available on the loratadine profile page.
Summary for 021375
Tradename:ALAVERT
Applicant:Pfizer
Ingredient:loratadine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021375
Suppliers and Packaging for NDA: 021375
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALAVERT loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021375 NDA Wyeth Consumer Healthcare LLC 0573-2620 0573-2620-01 50 POUCH in 1 BOX (0573-2620-01) > 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH
ALAVERT loratadine TABLET, ORALLY DISINTEGRATING;ORAL 021375 NDA Wyeth Consumer Healthcare LLC 0573-2620 0573-2620-19 18 BLISTER PACK in 1 CARTON (0573-2620-19) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Dec 19, 2002TE:RLD:No

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Cipla
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Express Scripts
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Medtronic
Fish and Richardson
Deloitte

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