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Details for New Drug Application (NDA): 021993

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NDA 021993 describes CLARITIN REDITABS, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the CLARITIN REDITABS profile page.

The generic ingredient in CLARITIN REDITABS 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: 021993

Tradename:
CLARITIN REDITABS
Applicant:
Bayer Healthcare Llc
Ingredient:
loratadine
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021993

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN REDITABS
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL 021993 NDA MSD Consumer Care, Inc. 11523-7202 11523-7202-1 3 BLISTER PACK in 1 CARTON (11523-7202-1) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
CLARITIN REDITABS
loratadine
TABLET, ORALLY DISINTEGRATING;ORAL 021993 NDA MSD Consumer Care, Inc. 11523-7202 11523-7202-3 1 BLISTER PACK in 1 CARTON (11523-7202-3) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Dec 12, 2006TE:RLD:Yes


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