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Details for New Drug Application (NDA): 203826

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NDA 203826 describes PHENYLEPHRINE HYDROCHLORIDE, which is a drug marketed by Paragon Bioteck, Akorn Inc, West Ward Pharm Corp, Vintage, and Hi-tech Pharmacal, and is included in five NDAs. It is available from five 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 drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the phenylephrine hydrochloride; promethazine hydrochloride profile page.

Summary for NDA: 203826

Tradename:
PHENYLEPHRINE HYDROCHLORIDE
Applicant:
West Ward Pharm Corp
Ingredient:
phenylephrine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203826

Mechanism of ActionAdrenergic alpha1-Agonists

Suppliers and Packaging for NDA: 203826

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride
SOLUTION;IV (INFUSION) 203826 NDA West-Ward Pharmaceutical Corp. 0641-6142 0641-6142-25 25 VIAL in 1 CARTON (0641-6142-25) > 1 mL in 1 VIAL (0641-6142-01)
PHENYLEPHRINE HYDROCHLORIDE
phenylephrine hydrochloride
SOLUTION;IV (INFUSION) 203826 NDA General Injectables & Vaccines, Inc 52584-142 52584-142-01 1 VIAL in 1 BAG (52584-142-01) > 1 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength10MG/ML (10MG/ML)
Approval Date:Dec 20, 2012TE:RLD:Yes


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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