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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207636


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NDA 207636 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Akorn, Caplin, Eugia Pharma, Hikma Pharms, Hospira, Inforlife, Mylan Asi, Navinta Llc, and Somerset Theraps Llc, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 207636
Tradename:ROPIVACAINE HYDROCHLORIDE
Applicant:Somerset Theraps Llc
Ingredient:ropivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207636
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 207636
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 207636 ANDA Somerset Therapeutics, LLC 70069-061 70069-061-25 25 VIAL in 1 CARTON (70069-061-25) > 10 mL in 1 VIAL (70069-061-01)
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 207636 ANDA Somerset Therapeutics, LLC 70069-062 70069-062-25 25 VIAL in 1 CARTON (70069-062-25) > 20 mL in 1 VIAL (70069-062-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:Jun 15, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Jun 15, 2018TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength100MG/20ML (5MG/ML)
Approval Date:Jun 15, 2018TE:APRLD:No

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