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Details for New Drug Application (NDA): 020533

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NDA 020533 describes NAROPIN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAROPIN profile page.

The generic ingredient in NAROPIN 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: 020533

Tradename:
NAROPIN
Applicant:
Fresenius Kabi Usa
Ingredient:
ropivacaine hydrochloride
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 020533

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 020533

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION 020533 NDA General Injectables & Vaccines, Inc 52584-286 52584-286-35 1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION 020533 NDA Fresenius Kabi USA, LLC 63323-285 63323-285-10 5 BLISTER PACK in 1 BOX (63323-285-10) > 1 AMPULE in 1 BLISTER PACK > 10 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:May 1, 1998TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Sep 24, 1996TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength100MG/20ML (5MG/ML)
Approval Date:May 1, 1998TE:APRLD:No

Expired Orange Book Patents for NDA: 020533

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-005Sep 24, 19965,670,524► subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-004Sep 24, 19965,670,524► subscribe
Fresenius Kabi Usa
NAROPIN
ropivacaine hydrochloride
SOLUTION;INJECTION020533-001May 1, 19984,695,576► subscribe
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