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Details for New Drug Application (NDA): 021330

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NDA 021330 describes COMMIT, which is a drug marketed by Glaxosmithkline Cons and is included in one NDA. It is available from three suppliers. Additional details are available on the COMMIT profile page.

The generic ingredient in COMMIT 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: 021330

Tradename:
COMMIT
Applicant:
Glaxosmithkline Cons
Ingredient:
nicotine polacrilex
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021330

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL 021330 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0510 0135-0510-01 3 CONTAINER in 1 CARTON (0135-0510-01) > 24 LOZENGE in 1 CONTAINER
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL 021330 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0135-0510 0135-0510-02 7 CONTAINER in 1 CARTON (0135-0510-02) > 24 LOZENGE in 1 CONTAINER

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 2MG BASE
Approval Date:Oct 31, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TROCHE/LOZENGE;ORALStrengthEQ 4MG BASE
Approval Date:Oct 31, 2002TE:RLD:Yes

Expired Orange Book Patents for NDA: 021330

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL021330-001Oct 31, 20025,110,605► subscribe
Glaxosmithkline Cons
COMMIT
nicotine polacrilex
TROCHE/LOZENGE;ORAL021330-002Oct 31, 20025,110,605► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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