MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE | N213135 | AZURITY PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BRAINTREE LABORATORIES, INC. et al v. HETERO USA, INC. et al 4 patentsANDA 220421sodium sulfate, magnesium sulfate, and potassium chloride | D.N.J. | 2025-07-22 | Active | — |
BRAINTREE LABORATORIES, INC. et al v. ALKEM LABORATORIES LIMITED 4 patentsANDA 220426sodium sulfate, magnesium sulfate, and potassium chloride | D.N.J. | 2025-06-25 | Active | — |
BRAINTREE LABORATORIES, INC. et al v. APPCO PHARMA LLC et al 4 patentsANDA 220327sodium sulfate, magnesium sulfate, and potassium chloride | D.N.J. | 2025-06-13 | Terminated 2025-09-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Braintree SEBELA PHARMACEUTICALS FDA-2021-P-0376 Braintree Sebela Pharmaceuticals filed this citizen petition on April 12, 2021, requesting that the FDA refrain from approving any new drug application or abbreviated new drug application under Sections 505(b) and 505(j) for tablet-based or tablet-containing colonoscopy preparations unless the appli | 505(q) | 2021-04-13 | Withdrawn | Braintree SEBELA PHARMACEUTICALS |
Source: Regulations.gov. FDA citizen petitions matched by application number.
SUTAB (magnesium sulfate; potassium chloride; sodium sulfate) received an AB therapeutic equivalence rating from the FDA.
New: AB