Application 091310
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 100MG | No | No |
| 002 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42192-617 | Benzonatate | Benzonatate | Acella Pharmaceuticals, LLC | ANDA | Current |
| 42192-618 | Benzonatate | Benzonatate | Acella Pharmaceuticals, LLC | ANDA | Current |
| 71205-659 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-659 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-659 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-659 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-662 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-885 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-885 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-886 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-886 | Benzonatate | Benzonatate | Proficient Rx LP | ANDA | Current |