FDA Orange Book · active-ingredient family
Magnesium sulfate; potassium sulfate; sodium sulfate
Magnesium sulfate; potassium sulfate; sodium sulfate is approved as 2 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COLPREP KIT · NDA 204553
2
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLPREP KITRLD | GATOR PHARMS | NDA 204553 | — | Dec 27, 2016 | |
| SUPREP BOWEL PREP KITRLD | AZURITY | NDA 022372 | AA | Aug 05, 2010 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | ANNORA PHARMA | ANDA 212903 | AA | Oct 18, 2024 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | PAI HOLDINGS | ANDA 209941 | AA | Jul 15, 2024 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | BIONPHARMA | ANDA 204135 | AA | Jun 24, 2024 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | TARO | ANDA 206431 | AA | Mar 19, 2024 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | ALKEM LABS LTD | ANDA 213924 | AA | Dec 29, 2023 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | STRIDES PHARMA INTL | ANDA 215469 | AA | Nov 22, 2023 | |
| SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE | NOVEL LABS INC | ANDA 202511 | AA | Feb 23, 2017 |
Marketing exclusivity (1)
- ODE-315Orphan-drug exclusivity (7 years)
Aug 05, 2027
in 1 yr 2 mo
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.
Magnesium sulfate; potassium sulfate; sodium sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
