Details for New Drug Application (NDA): 021928
NDA 021928 describes CHANTIX, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from three suppliers. Additional details are available on the CHANTIX profile page.
The generic ingredient in CHANTIX is varenicline tartrate. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
The generic ingredient in CHANTIX is varenicline tartrate. There is one drug master file entry for this compound. Thirty suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.
Summary for 021928
| Tradename: | CHANTIX |
| Applicant: | Pf Prism Cv |
| Ingredient: | varenicline tartrate |
| Patents: | 0 |
Pharmacology for NDA: 021928
| Mechanism of Action | Cholinergic Agonists Partial Cholinergic Nicotinic Agonists |
Medical Subject Heading (MeSH) Categories for 021928
Suppliers and Packaging for NDA: 021928
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CHANTIX | varenicline tartrate | TABLET;ORAL | 021928 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0468 | 0069-0468-56 | 56 TABLET, FILM COATED in 1 BOTTLE (0069-0468-56) |
| CHANTIX | varenicline tartrate | TABLET;ORAL | 021928 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0469 | 0069-0469-28 | 56 TABLET, FILM COATED in 1 BLISTER PACK (0069-0469-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 10, 2006 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 10, 2006 | TE: | AB | RLD: | Yes | ||||
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