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Details for New Drug Application (NDA): 204634

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NDA 204634 describes ETHACRYNATE SODIUM, which is a drug marketed by Mylan Institutional and Par Sterile Products and is included in two NDAs. It is available from two suppliers. Additional details are available on the ETHACRYNATE SODIUM profile page.

The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.

Summary for NDA: 204634

Tradename:
ETHACRYNATE SODIUM
Applicant:
Mylan Institutional
Ingredient:
ethacrynate sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204634

Suppliers and Packaging for NDA: 204634

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHACRYNATE SODIUM
ethacrynate sodium
INJECTABLE;INJECTION 204634 ANDA Mylan Institutional LLC 67457-297 67457-297-50 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-297-50) > 50 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Aug 23, 2016TE:APRLD:No


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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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