Details for New Drug Application (NDA): 070553
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NDA 070553 describes SENSORCAINE, which is a drug marketed by Fresenius Kabi Usa and is included in eight NDAs. It is available from four suppliers. Additional details are available on the SENSORCAINE profile page.
The generic ingredient in SENSORCAINE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
The generic ingredient in SENSORCAINE is bupivacaine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride profile page.
Summary for 070553
| Tradename: | SENSORCAINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | bupivacaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 070553
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 070553
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070553 | ANDA | Henry Schein, Inc. | 0404-9946 | 0404-9946-10 | 1 VIAL in 1 BAG (0404-9946-10) / 10 mL in 1 VIAL |
| SENSORCAINE | bupivacaine hydrochloride | INJECTABLE;INJECTION | 070553 | ANDA | Fresenius Kabi USA, LLC | 63323-466 | 63323-466-39 | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-466-39) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-466-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
| Approval Date: | May 21, 1986 | TE: | AP | RLD: | No | ||||
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