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AstraZeneca
Farmers Insurance
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US Army
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Generated: October 17, 2017

DrugPatentWatch Database Preview

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:
1
Applicant:
1
Ingredient:
1
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 Bayer HealthCare LLC. 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 Bayer HealthCare LLC. 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, 2002► Subscribe► Subscribe
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 2002► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Queensland Health
Chinese Patent Office
AstraZeneca
Fish and Richardson
Citi
Boehringer Ingelheim
Johnson and Johnson
Novartis

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