FDA Orange Book · active-ingredient family
Citric acid; lactic acid; potassium bitartrate
Citric acid; lactic acid; potassium bitartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:PHEXX · NDA 208352
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · gel
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHEXXRLD | EVOFEM INC | NDA 208352 | — | May 22, 2020 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11337989 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
| 11992472 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
| 10568855 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
| 11439610 | Mar 15, 2033 | in 6 yr 10 mo | SubstanceProduct |
Citric acid; lactic acid; potassium bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
