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Loratadine; pseudoephedrine sulfate - Generic Drug Details

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Loratadine; pseudoephedrine sulfate is the generic ingredient in three branded drugs marketed by Actavis Labs Fl Inc, Impax Labs, Sun Pharm Inds Ltd, and Bayer Healthcare Llc, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for loratadine; pseudoephedrine sulfate. Forty-six suppliers are listed for this compound.

Summary for Generic Name: loratadine; pseudoephedrine sulfate

Tradenames:3
Patents:0
Applicants:4
NDAs:7
Drug Master File Entries: see list39
Suppliers / Packaging: see list46
Formulation / Manufacturing:see details

Pharmacology for Ingredient: loratadine; pseudoephedrine sulfate

Clinical Trials for: loratadine; pseudoephedrine sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Ltd
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL076557-001Sep 22, 2004OTCNo<disabled><disabled>
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 2002OTCYes<disabled><disabled>
Actavis Labs Fl Inc
LORATADINE AND PSEUDOEPHEDRINE SULFATE
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL076208-001Jan 28, 2004DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: loratadine; pseudoephedrine sulfate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Healthcare Llc
CLARITIN-D 24 HOUR
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL020470-002Nov 27, 20024,863,931*PED<disabled>
Bayer Healthcare Llc
CLARITIN-D
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL019670-002Nov 27, 20024,659,716*PED<disabled>
Bayer Healthcare Llc
CLARITIN-D 24 HOUR
loratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL020470-002Nov 27, 20024,659,716*PED<disabled>
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