Details for New Drug Application (NDA): 020066
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NDA 020066 describes NICORETTE (MINT), which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from two suppliers. Additional details are available on the NICORETTE (MINT) profile page.
The generic ingredient in NICORETTE (MINT) is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
The generic ingredient in NICORETTE (MINT) is nicotine polacrilex. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the nicotine polacrilex profile page.
Summary for 020066
| Tradename: | NICORETTE (MINT) |
| Applicant: | Haleon Us Holdings |
| Ingredient: | nicotine polacrilex |
| Patents: | 1 |
Suppliers and Packaging for NDA: 020066
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NICORETTE | nicotine polacrilex | GUM, CHEWING;BUCCAL | 020066 | NDA | Haleon US Holdings LLC | 0135-0158 | 0135-0158-07 | 1 BLISTER PACK in 1 CARTON (0135-0158-07) / 110 GUM, CHEWING in 1 BLISTER PACK |
| NICORETTE | nicotine polacrilex | GUM, CHEWING;BUCCAL | 020066 | NDA | Haleon US Holdings LLC | 0135-0158 | 0135-0158-10 | 1 BLISTER PACK in 1 CARTON (0135-0158-10) / 170 GUM, CHEWING in 1 BLISTER PACK |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GUM, CHEWING;BUCCAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Feb 9, 1996 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 003
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GUM, CHEWING;BUCCAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Dec 23, 1998 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | OTC | Dosage: | GUM, CHEWING;BUCCAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Sep 25, 2000 | TE: | RLD: | Yes | |||||
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