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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 two 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. Twelve suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
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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