FDA Orange Book · active-ingredient family
Magnesium sulfate
Magnesium sulfate is approved as 3 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MAGNESIUM SULFATE IN PLASTIC CONTAINER · NDA 020309
3
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAGNESIUM SULFATE IN PLASTIC CONTAINERRLD×5 | HOSPIRA | NDA 020309 | AP | Jan 26, 2007 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERRLD×2 | HOSPIRA | NDA 020488 | AP | Jul 11, 1995 | |
| MAGNESIUM SULFATERLD×4 | FRESENIUS KABI USA | NDA 019316 | AP | Sep 08, 1986 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAGNESIUM SULFATE×4 | BAXTER HLTHCARE CORP | ANDA 211966 | — | Jan 08, 2026 | |
| MAGNESIUM SULFATE×4 | ASPIRO | ANDA 219777 | AP | May 28, 2025 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×2 | AMNEAL | ANDA 216597 | AP | Feb 15, 2023 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×3 | MILLA PHARMS | ANDA 209642 | AP | Nov 08, 2021 | |
| MAGNESIUM SULFATE×3 | B BRAUN MEDICAL | ANDA 207967 | AP | Apr 26, 2021 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | B BRAUN MEDICAL | ANDA 207966 | AP | Oct 27, 2020 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BAXTER HLTHCARE CORP | ANDA 211965 | AP | Aug 11, 2020 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×2 | GLAND | ANDA 213917 | AP | Jul 10, 2020 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×2 | MYLAN LABS LTD | ANDA 209911 | — | Sep 14, 2018 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | PHARMOBEDIENT | ANDA 209932 | AP | Sep 10, 2018 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×5 | HQ SPCLT PHARMA | ANDA 207350 | AP | Dec 06, 2017 | |
| MAGNESIUM SULFATE IN PLASTIC CONTAINER×5 | FRESENIUS KABI USA | ANDA 206485 | AP | Mar 15, 2016 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 206486 | AP | Mar 07, 2016 | |
| MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER | HQ SPCLT PHARMA | ANDA 207349 | AP | Mar 02, 2016 | |
| MAGNESIUM SULFATE | HOSPIRA | ANDA 202411 | AP | May 14, 2015 | |
| MAGNESIUM SULFATE | EXELA PHARMA | ANDA 206039 | — | Dec 18, 2014 | |
| MAGNESIUM SULFATE | HOSPIRA | ANDA 075151 | AP | Apr 25, 2000 |
Marketing exclusivity (2)
- CGTFDA marketing exclusivity
Feb 01, 2026
5 mo ago
- CGTFDA marketing exclusivity
Feb 01, 2026
5 mo ago
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
