Details for New Drug Application (NDA): 080407
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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 080407
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | West-ward Pharms Int |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 080407
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 080407
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 080407 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9575 | 0143-9575-10 | 10 VIAL, MULTI-DOSE in 1 PACKAGE (0143-9575-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9575-01) |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 080407 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9576 | 0143-9576-25 | 25 VIAL, MULTI-DOSE in 1 PACKAGE (0143-9576-25) / 2 mL in 1 VIAL, MULTI-DOSE (0143-9576-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No |
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