Details for New Drug Application (NDA): 211081
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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. Three suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.
Summary for 211081
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Provepharm Sas |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 211081
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 211081
Suppliers and Packaging for NDA: 211081
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 211081 | ANDA | Apollo Pharmaceuticals Inc. | 61990-0211 | 61990-0211-3 | 25 VIAL in 1 CARTON (61990-0211-3) / 1 mL in 1 VIAL (61990-0211-0) |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 211081 | ANDA | Apollo Pharmaceuticals Inc. | 61990-0212 | 61990-0212-2 | 10 VIAL in 1 CARTON (61990-0212-2) / 5 mL in 1 VIAL (61990-0212-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
Approval Date: | Jul 17, 2020 | TE: | AP1 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
Approval Date: | Jul 17, 2020 | TE: | AP1 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 100MG/10ML (10MG/ML) | ||||
Approval Date: | Jul 17, 2020 | TE: | AP1 | RLD: | No |
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