ED BRON GP is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Edwards Pharmaceuticals, Inc.. The primary component is Guaifenesin; Phenylephrine Hydrochloride.
Product ID | 0485-0208_43f06e29-011d-4c45-96a2-c15fa4d90bac |
NDC | 0485-0208 |
Product Type | Human Otc Drug |
Proprietary Name | ED BRON GP |
Generic Name | Guaifenesin And Phenylephrine |
Dosage Form | Liquid |
Route of Administration | ORAL |
Marketing Start Date | 2012-06-01 |
Marketing Category | OTC MONOGRAPH FINAL / UNAPPROVED DRUG OTHER |
Application Number | part341 |
Labeler Name | EDWARDS PHARMACEUTICALS, INC. |
Substance Name | GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
Active Ingredient Strength | 100 mg/5mL; mg/5mL |
Pharm Classes | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
NDC Exclude Flag | N |
Listing Certified Through | 2023-12-31 |
Marketing Start Date | 2012-06-01 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | unapproved drug other |
Product Type | HUMAN OTC DRUG |
Billing Unit | ML |
Marketing Start Date | 2012-06-01 |
Ingredient | Strength |
---|---|
GUAIFENESIN | 100 mg/5mL |
SPL SET ID: | b1fca5aa-d877-45e0-b074-dcbc6af94ee3 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ED BRON GP 86330989 4682161 Live/Registered |
Edwards Pharmaceuticals, Inc. 2014-07-08 |