Details for New Drug Application (NDA): 210696
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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 210696
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210696
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 210696
Suppliers and Packaging for NDA: 210696
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 210696 | ANDA | Eugia US LLC | 55150-300 | 55150-300-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-300-25) / 1 mL in 1 VIAL, SINGLE-DOSE |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 210696 | ANDA | Medical Purchasing Solutions, LLC | 71872-7267 | 71872-7267-1 | 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7267-1) / 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: | Jan 7, 2021 | TE: | AP2 | RLD: | No |
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