Orange Book product · Brand (NDA)
PLENVU
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
At a glance
May 04, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 04, 2018
8 yr 3 mo ago
Today
Patent 10780112 expires
Listed drug product patent expiration.
Mar 09, 2032
in 5 yr 10 mo
Patent 10792306 expires
Listed drug product patent expiration.
Mar 09, 2032
in 5 yr 10 mo
Patent 11529368 expires
Listed drug product patent expiration.
Mar 09, 2032
in 5 yr 10 mo
Patent 10646512 expires
Listed drug product patent expiration.
Mar 25, 2032
in 5 yr 10 mo
Patent 9592252 expires
Listed drug product patent expiration.
Aug 11, 2032
in 6 yr 3 mo
Patent 10016504 expires
Listed drug product patent expiration.
Sep 10, 2033
in 7 yr 4 mo
Patent 10918723 expires
Listed method-of-use patent (U-2310) expiration.
Sep 10, 2033
in 7 yr 4 mo
Patent 12083179 expires
Listed drug product patent expiration.
Sep 10, 2033
in 7 yr 4 mo
Patent 8999313 expires
Listed drug product patent expiration.
Sep 10, 2033
in 7 yr 4 mo
Patent 9326969 expires
Listed method-of-use patent (U-2310) expiration.
Sep 10, 2033
in 7 yr 4 mo
Patent 9707297 expires
Listed drug product patent expiration.
Sep 10, 2033
in 7 yr 4 mo
Pharmaceutical detail
Active ingredient
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Strength
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 209381
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.
- 2006MOVIPREPBrand (NDA)
NDA 021881 · SALIX PHARMS
- 2024PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDGeneric (ANDA)
ANDA 207498 · TARO
- 2012PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACIDGeneric (ANDA)
ANDA 090145 · NOVEL LABS INC
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10780112 | Mar 09, 2032 | in 5 yr 10 mo | Product |
| 10792306 | Mar 09, 2032 | in 5 yr 10 mo | ProductU-2310 |
| 11529368 | Mar 09, 2032 | in 5 yr 10 mo | ProductU-2310 |
| 10646512 | Mar 25, 2032 | in 5 yr 10 mo | Product |
| 9592252 | Aug 11, 2032 | in 6 yr 3 mo | ProductU-2310 |
| 10016504 | Sep 10, 2033 | in 7 yr 4 mo | Product |
| 10918723 | Sep 10, 2033 | in 7 yr 4 mo | U-2310 |
| 12083179 | Sep 10, 2033 | in 7 yr 4 mo | ProductU-2310 |
| 8999313 | Sep 10, 2033 | in 7 yr 4 mo | Product |
| 9326969 | Sep 10, 2033 | in 7 yr 4 mo | U-2310 |
| 9707297 | Sep 10, 2033 | in 7 yr 4 mo | Product |
