Details for New Drug Application (NDA): 213237

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NDA 213237 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-three 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.

Tradename:	PHENYLEPHRINE HYDROCHLORIDE
Applicant:	Accord Hlthcare
Ingredient:	phenylephrine hydrochloride
Patents:	0

Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Sympathomimetics
Vasoconstrictor Agents

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/ML (10MG/ML)
Approval Date:	Jul 1, 2020	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	50MG/5ML (10MG/ML)
Approval Date:	Jul 1, 2020	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/10ML (10MG/ML)
Approval Date:	Jul 1, 2020	TE:		RLD:	No

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