Details for New Drug Application (NDA): 088328
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The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 088328
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | Hospira |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 088328
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 088328
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088328 | ANDA | Henry Schein, Inc. | 0404-9885 | 0404-9885-50 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9885-50) / 50 mL in 1 VIAL, SINGLE-DOSE |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 088328 | ANDA | Hospira, Inc. | 0409-4278 | 0409-4278-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.5% | ||||
Approval Date: | May 17, 1984 | TE: | AP | RLD: | No |
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