Details for New Drug Application (NDA): 205612
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The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 205612
Tradename: | ROPIVACAINE HYDROCHLORIDE |
Applicant: | Eugia Pharma |
Ingredient: | ropivacaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205612
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 205612
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 205612 | ANDA | Eugia US 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 | ropivacaine hydrochloride | SOLUTION;INJECTION | 205612 | ANDA | Eugia US LLC | 55150-196 | 55150-196-99 | 1 BOTTLE, GLASS in 1 CARTON (55150-196-99) / 100 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 40MG/20ML (2MG/ML) | ||||
Approval Date: | Jul 13, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 200MG/100ML (2MG/ML) | ||||
Approval Date: | Jul 13, 2016 | TE: | AP | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 100MG/20ML (5MG/ML) | ||||
Approval Date: | Jul 13, 2016 | TE: | AP | RLD: | No |
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