Details for New Drug Application (NDA): 211079
✉ Email this page to a colleague
The generic ingredient in PHENYLEPHRINE HYDROCHLORIDE is phenylephrine hydrochloride; promethazine hydrochloride. There are twenty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 211079
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Amneal |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211079
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 211079
Suppliers and Packaging for NDA: 211079
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 211079 | ANDA | Henry Schein, Inc. | 0404-9931 | 0404-9931-99 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9931-99) / 1 mL in 1 VIAL, SINGLE-DOSE |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 211079 | ANDA | Cardinal Health 107, LLC | 55154-8226 | 55154-8226-5 | 5 VIAL, SINGLE-DOSE in 1 BAG (55154-8226-5) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
Approval Date: | Jul 5, 2018 | TE: | AP1 | RLD: | No |
Complete Access Available with Subscription