Magnesium sulfate; potassium sulfate; sodium sulfate
Magnesium sulfate; potassium sulfate; sodium sulfate: 2 brands, 8 generics; first approved Aug 05, 2010; generic available.
Generic available: 8 ANDA applications approved.
Brand (NDA) products
- COLPREP KITRLDGATOR PHARMSNDA 2045532016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT POWDER ORAL Discontinued — - AZURITYNDA 0223722010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA
Generic (ANDA) products (8)
- MACLEODS PHARMS LTDANDA 2194292026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - ANNORA PHARMAANDA 2129032024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - PAI HOLDINGSANDA 2099412024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - BIONPHARMAANDA 2041352024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - TAROANDA 2064312024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - ALKEM LABS LTDANDA 2139242023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - STRIDES PHARMA INTLANDA 2154692023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA - NOVEL LABS INCANDA 2025112017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT SOLUTION ORAL Rx AA
Patent & exclusivity timeline
Marketing exclusivity
- ODE-315Orphan-drug exclusivity (7 years)
in 11 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.
Approval history
Approvals span 2010–2026 across 10 FDA applications.
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.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
