Application 213135
- Type
- NDA
- Sponsor
- BRAINTREE LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUTAB | SODIUM SULFATE;MAGNESIUM SULFATE;POTASSIUM | TABLET;ORAL | 1.479G;0.225G;0.188G | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 52268-201 | SUTAB | sodium sulfate, magnesium sulfate, and potassium chloride | Braintree Laboratories, Inc. | NDA | Current |
| 52268-201 | SUTAB | sodium sulfate, magnesium sulfate, and potassium chloride | Braintree Laboratories, Inc. | NDA | Current |
| 52268-201 | SUTAB | sodium sulfate, magnesium sulfate, and potassium chloride | Braintree Laboratories, Inc. | NDA | Current |