| NDC Code | 58602-834-77 |
|---|
| Package Description | 1 BLISTER PACK in 1 CARTON (58602-834-77) / 12 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
|---|
| Product NDC | 58602-834 |
|---|
| Product Type Name | HUMAN OTC DRUG |
|---|
| Proprietary Name | Guaifenesin And Pseudoephedrine Hcl |
|---|
| Non-Proprietary Name | Guaifenesin And Pseudoephedrine Hcl |
|---|
| Dosage Form | TABLET, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20200325 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA213203 |
|---|
| Manufacturer | Aurohealth LLC |
|---|
| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
|---|
| Strength | 1200; 120 |
|---|
| Strength Unit | mg/1; mg/1 |
|---|
| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC] |
|---|