Application 202819
- Type
- ANDA
- Sponsor
- SIGMAPHARM LABS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM PHENYLBUTYRATE | SODIUM PHENYLBUTYRATE | POWDER;ORAL | 3GM/TEASPOONFUL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42794-086 | Sodium Phenylbutyrate | Sodium Phenylbutyrate | Sigmapharm Laboratories, LLC | ANDA | Current |
| 42794-086 | Sodium Phenylbutyrate | Sodium Phenylbutyrate | Sigmapharm Laboratories, LLC | ANDA | Current |