Details for New Drug Application (NDA): 070552
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The generic ingredient in SENSORCAINE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 070552
Tradename: | SENSORCAINE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 070552
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 070552
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070552 | ANDA | Fresenius Kabi USA, LLC | 63323-464 | 63323-464-31 | 5 VIAL, SINGLE-DOSE in 1 BOX (63323-464-31) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-03) |
SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070552 | ANDA | Fresenius Kabi USA, LLC | 63323-464 | 63323-464-37 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25% | ||||
Approval Date: | May 21, 1986 | TE: | AP | RLD: | No |
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