Orange Book product · Brand (NDA)
MOVIPREP
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
At a glance
Aug 02, 2006
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 02, 2006
20 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE
Strength
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AA
Application
NDA 021881
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.
- 2018PLENVUBrand (NDA)
NDA 209381 · SALIX
- 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
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
