Details for New Drug Application (NDA): 070968
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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 070968
Tradename: | SENSORCAINE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | bupivacaine hydrochloride; epinephrine bitartrate |
Patents: | 0 |
Pharmacology for NDA: 070968
Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 070968
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SENSORCAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 070968 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1399 | 51662-1399-1 | 50 mL in 1 VIAL, MULTI-DOSE (51662-1399-1) |
SENSORCAINE | bupivacaine hydrochloride; epinephrine bitartrate | INJECTABLE;INJECTION | 070968 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1399 | 51662-1399-2 | 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1399-2) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5%;0.0091MG/ML | ||||
Approval Date: | Oct 13, 1987 | TE: | AP | RLD: | No |
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