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Details for New Drug Application (NDA): 205612

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NDA 205612 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Navinta Llc, Aurobindo Pharma Ltd, Sagent Strides, Akorn Inc, and Hospira, and is included in five NDAs. It is available from five 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. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for NDA: 205612

Aurobindo Pharma Ltd
ropivacaine hydrochloride
Formulation / Manufacturing:see details

Pharmacology for NDA: 205612

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 205612

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ropivacaine hydrochloride
SOLUTION;INJECTION 205612 ANDA AuroMedics Pharma LLC 55150-195 55150-195-20 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-195-20) > 20 mL in 1 VIAL, SINGLE-DOSE
ropivacaine hydrochloride
SOLUTION;INJECTION 205612 ANDA AuroMedics Pharma LLC 55150-196 55150-196-99 1 BOTTLE, GLASS in 1 CARTON (55150-196-99) > 100 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Jul 13, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength200MG/100ML (2MG/ML)
Approval Date:Jul 13, 2016TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength100MG/20ML (5MG/ML)
Approval Date:Jul 13, 2016TE:APRLD:No

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