| NDC Code | 45802-122-65 |
|---|
| Package Description | 30 BLISTER PACK in 1 CARTON (45802-122-65) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 45802-122 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Loratadine D |
|---|
| Non-Proprietary Name | Loratadine, Pseudoephedrine Sulfate |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20180410 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA076050 |
|---|
| Manufacturer | Padagis Israel Pharmaceuticals Ltd |
|---|
| Substance Name | LORATADINE; PSEUDOEPHEDRINE SULFATE |
|---|
| Strength | 5; 120 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
|---|