Orange Book product
NICOTINE POLACRILEX EQ 4MG BASE
Orange Book ANDA 078697 · P AND L DEVELOPMENT LLC · Over the counter
Key facts
| Proprietary name | NICOTINE POLACRILEX |
|---|---|
| Active ingredients | NICOTINE POLACRILEX |
| Strength | EQ 4MG BASE |
| Dosage form | GUM, CHEWING |
| Route | BUCCAL |
| Application | ANDA078697 |
| Applicant holder | P AND L DEVELOPMENT LLC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 29, 2008 |
At a glance
- 10–99 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.