FDA Orange Book · active-ingredient family
Lidocaine; tetracaine
Lidocaine; tetracaine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PLIAGLIS · NDA 021717
2
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · cream, patch
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PLIAGLISRLD | CRESCITA THERAP | NDA 021717 | — | Jun 29, 2006 | |
| SYNERARLD | GALEN SPECIALTY | NDA 021623 | — | Jun 23, 2005 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12558328 | Jan 14, 2031 | in 4 yr 8 mo | U-4421 |
| 10603293 | Jan 14, 2031 | in 4 yr 8 mo | Product |
| 10751305 | Jan 14, 2031 | in 4 yr 8 mo | Product |
| 10350180 | Jan 14, 2031 | in 4 yr 8 mo | Product |
Lidocaine; tetracaine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
