Details for New Drug Application (NDA): 091503
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NDA 091503 describes BUPIVACAINE HYDROCHLORIDE, which is a drug marketed by Aspiro, Civica, Eugia Pharma, Hikma Pharms, Hospira, Meitheal, Onesource Specialty, Somerset, B Braun Medical, Baxter Hlthcare Corp, Huons, and Intl Medicated, and is included in thirty-four NDAs. It is available from twenty-one suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 091503
| Tradename: | BUPIVACAINE HYDROCHLORIDE |
| Applicant: | Onesource Specialty |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091503
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 091503
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091503 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-116 | 70594-116-01 | 50 mL in 1 VIAL, MULTI-DOSE (70594-116-01) |
| BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 091503 | ANDA | Xellia Pharmaceuticals USA LLC | 70594-119 | 70594-119-01 | 50 mL in 1 VIAL, MULTI-DOSE (70594-119-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
| Approval Date: | Oct 18, 2011 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
| Approval Date: | Oct 18, 2011 | TE: | AP | RLD: | No | ||||
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