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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203510


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NDA 203510 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Alcon, Caplin, Mankind Pharma, Paragon Bioteck, Accord Hlthcare, Amneal, Aspiro, Avet Lifesciences, Be Pharms, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hainan Poly, Hikma, Meitheal, Provepharm Sas, Sagent Pharms Inc, Sandoz, and Genus, and is included in twenty-eight NDAs. It is available from thirty-four 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 203510
Pharmacology for NDA: 203510
Mechanism of ActionAdrenergic alpha1-Agonists
Suppliers and Packaging for NDA: 203510
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510 NDA Paragon BioTeck, Inc. 42702-102 42702-102-10 1 BOTTLE, DROPPER in 1 CARTON (42702-102-10) / 10 mL in 1 BOTTLE, DROPPER
PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION/DROPS;OPHTHALMIC 203510 NDA Paragon BioTeck, Inc. 42702-102 42702-102-15 1 BOTTLE, DROPPER in 1 CARTON (42702-102-15) / 15 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength2.5%
Approval Date:Mar 21, 2013TE:ATRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 14, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:DILATION OF THE PUPIL

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength10%
Approval Date:Mar 21, 2013TE:ATRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 14, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:DILATION OF THE PUPIL

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