Details for New Drug Application (NDA): 020165
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NDA 020165 describes NICODERM CQ, which is a drug marketed by Chattem Sanofi and is included in one NDA. It is available from four suppliers. Additional details are available on the NICODERM CQ profile page.
The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
The generic ingredient in NICODERM CQ is nicotine. There are thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020165
| Tradename: | NICODERM CQ |
| Applicant: | Chattem Sanofi |
| Ingredient: | nicotine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 020165
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0135-0194 | 0135-0194-01 | 7 PATCH in 1 CARTON (0135-0194-01) / 24 h in 1 PATCH |
| NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165 | NDA | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC | 0135-0194 | 0135-0194-02 | 14 PATCH in 1 CARTON (0135-0194-02) / 24 h in 1 PATCH |
Profile for product number 004
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 21MG/24HR | ||||
| Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 005
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 14MG/24HR | ||||
| Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 006
| Active Rx/OTC/Discontinued: | OTC | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 7MG/24HR | ||||
| Approval Date: | Aug 2, 1996 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020165
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-006 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-004 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-005 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-006 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-006 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Chattem Sanofi | NICODERM CQ | nicotine | FILM, EXTENDED RELEASE;TRANSDERMAL | 020165-006 | Aug 2, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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