Details for New Drug Application (NDA): 205612
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NDA 205612 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland, Hikma, Hospira, Inforlife, Kindos, Mylan Labs Ltd, Navinta Llc, Neocubes Pharma, Rising, and Somerset Theraps Llc, and is included in sixteen NDAs. It is available from eighteen 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. Nineteen suppliers are listed for this compound. 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. Nineteen 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 |
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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