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Last Updated: May 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211081

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NDA 211081 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Akorn, Paragon Bioteck, Accord Hlthcare, Amneal, Aurobindo Pharma Ltd, Caplin, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Meitheal, Par Sterile Products, Provepharm Sas, Sagent Pharms Inc, Sandoz Inc, and Pharm Assoc, and is included in twenty NDAs. It is available from seventeen suppliers. There is one patent protecting this drug. Additional details are available on the PHENYLEPHRINE HYDROCHLORIDE profile page.

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
Formulation / Manufacturing:see details
Pharmacology for NDA: 211081
Mechanism of ActionAdrenergic alpha1-Agonists
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:RXDosage:SOLUTION;INTRAVENOUSStrength10MG/ML (10MG/ML)
Approval Date:Jul 17, 2020TE:AP1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength50MG/5ML (10MG/ML)
Approval Date:Jul 17, 2020TE:AP1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/10ML (10MG/ML)
Approval Date:Jul 17, 2020TE:AP1RLD:No

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