Details for New Drug Application (NDA): 070967
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NDA 070967 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 070967
| Tradename: | SENSORCAINE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | bupivacaine hydrochloride; epinephrine bitartrate |
| Patents: | 0 |
Pharmacology for NDA: 070967
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 070967
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SENSORCAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 070967 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1397 | 51662-1397-1 | 50 mL in 1 VIAL, MULTI-DOSE (51662-1397-1) |
| SENSORCAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 070967 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1397 | 51662-1397-2 | 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1397-2) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25%;0.0091MG/ML | ||||
| Approval Date: | Oct 13, 1987 | TE: | AP | RLD: | No | ||||
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