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. Twenty-two 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 |
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 | 63323-464-39 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-464-39) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-464-09) |
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) |
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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