Details for New Drug Application (NDA): 213237
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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 213237
Tradename: | PHENYLEPHRINE HYDROCHLORIDE |
Applicant: | Accord Hlthcare |
Ingredient: | phenylephrine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213237
Mechanism of Action | Adrenergic alpha1-Agonists |
Medical Subject Heading (MeSH) Categories for 213237
Suppliers and Packaging for NDA: 213237
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 213237 | ANDA | Accord Healthcare, Inc. | 16729-464 | 16729-464-08 | 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-464-08) / 1 mL in 1 VIAL, SINGLE-DOSE (16729-464-63) |
PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | SOLUTION;INTRAVENOUS | 213237 | ANDA | Accord Healthcare, Inc. | 16729-465 | 16729-465-03 | 10 CARTON in 1 CARTON (16729-465-03) / 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (16729-465-31) / 5 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10MG/ML (10MG/ML) | ||||
Approval Date: | Jul 1, 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 1, 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 1, 2020 | TE: | AP1 | RLD: | No |
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