Details for New Drug Application (NDA): 209968
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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 209968
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Avet Lifesciences |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209968
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 209968
Suppliers and Packaging for NDA: 209968
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 209968 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-620 | 23155-620-41 | 25 VIAL in 1 CARTON (23155-620-41) / 1 mL in 1 VIAL (23155-620-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
Approval Date: | Feb 28, 2023 | TE: | AP2 | RLD: | No |
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