| NDC Code | 71179-816-24 |
|---|
| Package Description | 3 BLISTER PACK in 1 CARTON (71179-816-24) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 71179-816 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Naproxen Sodium And Pseudoephedrine Hydrochloride Cold And Sinus |
|---|
| Non-Proprietary Name | Naproxen Sodium And Pseudoephedrine Hydrochloride |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20240807 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA211360 |
|---|
| Manufacturer | VESPYR BRANDS, INC. |
|---|
| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 220; 120 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-Adrenergic Agonist [EPC] |
|---|