Orange Book product
NICOTINE 21MG/24HR
Orange Book ANDA 074612 · DIFGEN PHARMACEUTICALS LLC · Over the counter
Key facts
| Proprietary name | NICOTINE |
|---|---|
| Active ingredients | NICOTINE |
| Strength | 21MG/24HR |
| Dosage form | FILM, EXTENDED RELEASE |
| Route | TRANSDERMAL |
| Application | ANDA074612 |
| Applicant holder | DIFGEN PHARMACEUTICALS LLC |
| Marketing status | Over the counter |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Oct 20, 1997 |
At a glance
- 1–9 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.