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Details for New Drug Application (NDA): 205108

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NDA 205108 describes SOTYLIZE, which is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the SOTYLIZE profile page.

The generic ingredient in SOTYLIZE is sotalol hydrochloride. There are ten drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the sotalol hydrochloride profile page.

Summary for NDA: 205108

Tradename:
SOTYLIZE
Applicant:
Arbor Pharms Llc
Ingredient:
sotalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205108

Mechanism of ActionAdrenergic beta-Antagonists
Physiological EffectCardiac Rhythm Alteration

Suppliers and Packaging for NDA: 205108

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTYLIZE
sotalol hydrochloride
SOLUTION;ORAL 205108 NDA Arbor Pharmaceuticals, Inc. 24338-530 24338-530-25 250 mL in 1 BOTTLE (24338-530-25)
SOTYLIZE
sotalol hydrochloride
SOLUTION;ORAL 205108 NDA Arbor Pharmaceuticals, Inc. 24338-530 24338-530-48 480 mL in 1 BOTTLE (24338-530-48)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength5MG/ML (5MG/ML)
Approval Date:Oct 22, 2014TE: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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