Orange Book product · Brand (NDA)
COLPREP KIT
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
At a glance
Dec 27, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 2016
9 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Strength
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Dosage form
POWDER
Route
ORAL
TE code
Not listed
Application
NDA 204553
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2010SUPREP BOWEL PREP KITBrand (NDA)
NDA 022372 · AZURITY
- 2024SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 212903 · ANNORA PHARMA
- 2024SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 209941 · PAI HOLDINGS
- 2024SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 204135 · BIONPHARMA
- 2024SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 206431 · TARO
- 2023SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 213924 · ALKEM LABS LTD
- 2023SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 215469 · STRIDES PHARMA INTL
- 2017SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATEGeneric (ANDA)
ANDA 202511 · 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.
