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Details for New Drug Application (NDA): 022360

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NDA 022360 describes NICORETTE, which is a drug marketed by Glaxosmithkline and Glaxosmithkline Cons and is included in three NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NICORETTE profile page.

The generic ingredient in NICORETTE is nicotine polacrilex. There are twenty-nine drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.

Summary for NDA: 022360

Tradename:
NICORETTE
Applicant:
Glaxosmithkline Cons
Ingredient:
nicotine polacrilex
Patents:2
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022360

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL 022360 NDA GlaxoSmithKline Consumer Healthcare LP 0135-0508 0135-0508-02 3 CONTAINER in 1 CARTON (0135-0508-02) > 27 LOZENGE in 1 CONTAINER
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL 022360 NDA GlaxoSmithKline Consumer Healthcare LP 0135-0508 0135-0508-03 5 CONTAINER in 1 CARTON (0135-0508-03) > 27 LOZENGE in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:May 18, 2009TE:RLD:No
Patent:8,501,164Patent Expiration:Jun 14, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:8,940,772Patent Expiration:Apr 30, 2029Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:May 18, 2009TE:RLD:Yes
Patent:8,501,164Patent Expiration:Jun 14, 2029Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022360

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-001May 18, 20095,110,605► subscribe
Glaxosmithkline Cons
NICORETTE
nicotine polacrilex
TROCHE/LOZENGE;ORAL022360-002May 18, 20095,110,605► subscribe
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