FDA Orange Book
Generic for Sutab
Sutab contains magnesium sulfate, potassium chloride and sodium sulfate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Sutab is magnesium sulfate, potassium chloride and sodium sulfate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sutab products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 0.225GM;0.188GM;1.479GM | Marketed (Rx) | AB | 1 | AB |
NDA 213135, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic magnesium sulfate, potassium chloride and sodium sulfate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 216095 | AB (A-rated, therapeutically equivalent) | May 28, 2026 | 0.225GM;0.188GM;1.479GM |
Sutab patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11382864 | August 4, 2037 | Method of use | U-3164 | 213135 |
| 11033498 | August 4, 2037 | Method of use | U-3164 | 213135 |
| 11638697 | August 4, 2037 | Drug product | None | 213135 |
| 10143656 | August 4, 2037 | Drug product | None | 213135 |
Sutab NDC codes
Questions
Is there a generic for Sutab?
Yes. The generic name for Sutab is magnesium sulfate, potassium chloride and sodium sulfate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sutab?
The active ingredient in Sutab is magnesium sulfate, potassium chloride and sodium sulfate, per the FDA Orange Book.
When does the Sutab patent expire?
The last patent listed for Sutab in the Orange Book expires August 4, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.