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Details for New Drug Application (NDA): 020533
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The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 020533
Tradename: | NAROPIN |
Applicant: | Fresenius Kabi Usa |
Ingredient: | ropivacaine hydrochloride |
Patents: | 4 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020533
Physiological Effect | Local 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 | 63323-285-67 | 12 BOTTLE in 1 CASE (63323-285-67) > 100 mL in 1 BOTTLE (63323-285-55) |
Paragraph IV (Patent) Challenges for 020533
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2015-09-03 |
NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2015-01-30 |
NAROPIN | SOLUTION;INJECTION | ropivacaine hydrochloride | 020533 | 2006-11-13 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 20MG/10ML (2MG/ML) | ||||
Approval Date: | May 1, 1998 | TE: | AP | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 40MG/20ML (2MG/ML) | ||||
Approval Date: | Sep 24, 1996 | TE: | AP | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 100MG/20ML (5MG/ML) | ||||
Approval Date: | May 1, 1998 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 020533
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