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Details for New Drug Application (NDA): 019670

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NDA 019670 describes CLARITIN-D, which is a drug marketed by Bayer Healthcare Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARITIN-D profile page.

The generic ingredient in CLARITIN-D 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: 019670

Tradename:
CLARITIN-D
Applicant:
Bayer Healthcare Llc
Ingredient:
loratadine; pseudoephedrine sulfate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019670

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL 019670 NDA MSD Consumer Care, Inc. 11523-7162 11523-7162-1 1 BLISTER PACK in 1 CARTON (11523-7162-1) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL 019670 NDA MSD Consumer Care, Inc. 11523-7162 11523-7162-2 2 BLISTER PACK in 1 CARTON (11523-7162-2) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;120MG
Approval Date:Nov 27, 2002TE:RLD:Yes

Expired Orange Book Patents for NDA: 019670

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 20024,659,716*PED► subscribe
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 20024,863,931*PED► subscribe
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