Orange Book product · Brand (NDA)
PHEXX
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
At a glance
May 22, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 22, 2020
6 yr 2 mo ago
Today
Patent 10568855 expires
Listed method-of-use patent (U-1) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11337989 expires
Listed method-of-use patent (U-1) expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11439610 expires
Listed drug substance patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 11992472 expires
Listed method-of-use patent (U-1) expiration.
Mar 15, 2033
in 6 yr 10 mo
Pharmaceutical detail
Active ingredient
CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE
Strength
1%;1.8%;0.4%
Dosage form
GEL
Route
VAGINAL
TE code
Not listed
Application
NDA 208352
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10568855 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
| 11337989 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
| 11439610 | Mar 15, 2033 | in 6 yr 10 mo | SubstanceProduct |
| 11992472 | Mar 15, 2033 | in 6 yr 10 mo | U-1 |
