| NDC Code | 46708-421-31 |
|---|
| Package Description | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-421-31) |
|---|
| Product NDC | 46708-421 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Carbamazepine |
|---|
| Non-Proprietary Name | Carbamazepine |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20250726 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA219939 |
|---|
| Manufacturer | Alembic Pharmaceuticals Limited |
|---|
| Substance Name | CARBAMAZEPINE |
|---|
| Strength | 200 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC] |
|---|