| NDC Code | 45802-721-62 |
|---|
| Package Description | 24 BLISTER PACK in 1 CARTON (45802-721-62) > 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 45802-721 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
|---|
| Non-Proprietary Name | Cetirizine Hcl, Pseudoephedrine Hcl |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20080410 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA077170 |
|---|
| Manufacturer | Padagis Israel Pharmaceuticals Ltd |
|---|
| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 5; 120 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
|---|