| NDC Code | 70000-0504-1 |
|---|
| Package Description | 10 BLISTER PACK in 1 CARTON (70000-0504-1) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 70000-0504 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Leader Allergy Relief D12 |
|---|
| Non-Proprietary Name | Loratadine, Pseudoephedrine Sulfate |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20200109 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA076050 |
|---|
| Manufacturer | Cardinal Health 110, LLC. dba Leader |
|---|
| Substance Name | LORATADINE; PSEUDOEPHEDRINE SULFATE |
|---|
| Strength | 5; 120 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
|---|