magnesium sulfate · Fresenius Kabi Usa · NDA 019316
Magnesium Sulfate
Earliest generic entry, as listed · earliest of 4 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 217461, Adaptis · 019316-001Approved 9 Jul 2026Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019316 · 001 · RLD | solution, intramuscular, intravenous | 5GM/10ML (500MG/ML) | open |
| 019316 · 002 · RLD | solution, intramuscular, intravenous | 1GM/2ML (500MG/ML) | open |
| 019316 · 003 · RLD | solution, intramuscular, intravenous | 10GM/20ML (500MG/ML) | open |
| 019316 · 004 · RLD | solution, intramuscular, intravenous | 25GM/50ML (500MG/ML) | open |