Orange Book product · Generic (ANDA)
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
At a glance
Mar 19, 2024
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 19, 2024
2 yr 3 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
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 206431
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
- 2016COLPREP KITBrand (NDA)
NDA 204553 · GATOR PHARMS
- 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
- 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.
