Details for New Drug Application (NDA): 071167
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NDA 071167 describes BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, which is a drug marketed by Hospira and is included in eight NDAs. It is available from two suppliers. Additional details are available on the BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
The generic ingredient in BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE is bupivacaine hydrochloride; epinephrine bitartrate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bupivacaine hydrochloride; epinephrine bitartrate profile page.
Summary for 071167
| Tradename: | BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE |
| Applicant: | Hospira |
| Ingredient: | bupivacaine hydrochloride; epinephrine |
| Patents: | 0 |
Pharmacology for NDA: 071167
| Mechanism of Action | Adrenergic alpha-Agonists Adrenergic beta-Agonists |
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 071167
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | bupivacaine hydrochloride; epinephrine | INJECTABLE;INJECTION | 071167 | ANDA | Hospira, Inc. | 0409-9043 | 0409-9043-01 | 25 CARTON in 1 BOX (0409-9043-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9043-11) / 50 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25%;0.005MG/ML | ||||
| Approval Date: | Jun 16, 1988 | TE: | RLD: | No | |||||
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