Details for New Drug Application (NDA): 212808
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NDA 212808 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Amneal, Caplin, Eugia Pharma, Gland Pharma Ltd, Hikma, Hospira, Inforlife, Mylan Labs Ltd, Navinta Llc, Rising, and Somerset Theraps Llc, and is included in thirteen NDAs. It is available from twelve 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. Fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 212808
| Tradename: | ROPIVACAINE HYDROCHLORIDE |
| Applicant: | Caplin |
| Ingredient: | ropivacaine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212808
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 212808
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 212808 | ANDA | Baxter Healthcare Corporation | 43066-015 | 43066-015-10 | 10 VIAL in 1 CARTON (43066-015-10) / 20 mL in 1 VIAL (43066-015-01) |
| ROPIVACAINE HYDROCHLORIDE | ropivacaine hydrochloride | SOLUTION;INJECTION | 212808 | ANDA | Baxter Healthcare Corporation | 43066-019 | 43066-019-10 | 10 VIAL in 1 CARTON (43066-019-10) / 20 mL in 1 VIAL (43066-019-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 40MG/20ML (2MG/ML) | ||||
| Approval Date: | Apr 9, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 100MG/20ML (5MG/ML) | ||||
| Approval Date: | Apr 9, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 150MG/30ML (5MG/ML) | ||||
| Approval Date: | Apr 9, 2020 | TE: | AP | RLD: | No | ||||
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