Details for New Drug Application (NDA): 204300
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NDA 204300 describes VAZCULEP, which is a drug marketed by Exela Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the VAZCULEP profile page.
The generic ingredient in VAZCULEP is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
The generic ingredient in VAZCULEP is phenylephrine hydrochloride. There are twenty-one drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride profile page.
Summary for 204300
| Tradename: | VAZCULEP |
| Applicant: | Exela Pharma |
| Ingredient: | phenylephrine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204300
| Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 204300
Suppliers and Packaging for NDA: 204300
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VAZCULEP | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 204300 | NDA | Exela Phrama Sciences, LLC | 51754-4000 | 51754-4000-3 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (51754-4000-3) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| VAZCULEP | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 204300 | NDA | Exela Phrama Sciences, LLC | 51754-4010 | 51754-4010-4 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-4010-4) / 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: | Jun 27, 2014 | TE: | AP1 | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Jun 27, 2014 | TE: | AP1 | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/10ML (10MG/ML) | ||||
| Approval Date: | Jun 27, 2014 | TE: | AP1 | RLD: | Yes | ||||
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