Details for New Drug Application (NDA): 071810
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The generic ingredient in BUPIVACAINE HYDROCHLORIDE 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 071810
Tradename: | BUPIVACAINE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | bupivacaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 071810
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 071810
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | bupivacaine hydrochloride | INJECTABLE;SPINAL | 071810 | ANDA | Hospira, Inc. | 0409-3613 | 0409-3613-01 | 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SPINAL | Strength | 0.75% | ||||
Approval Date: | Dec 11, 1987 | TE: | AP | RLD: | No |
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