Details for New Drug Application (NDA): 070585
✉ Email this page to a colleague
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 070585
Tradename: | BUPIVACAINE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070585
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 070585
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070585 | ANDA | Hospira, Inc. | 0409-1165 | 0409-1165-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1165-18) |
BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070585 | ANDA | Hospira, Inc. | 0409-1165 | 0409-1165-02 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1165-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1165-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.75% | ||||
Approval Date: | Mar 3, 1987 | TE: | AP | RLD: | No |
Complete Access Available with Subscription