Details for New Drug Application (NDA): 212821
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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 212821
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | Huons |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212821
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 212821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 212821 | ANDA | McKesson Corporation dba SKY Packaging | 63739-170 | 63739-170-24 | 10 VIAL in 1 BOX (63739-170-24) / 5 mL in 1 VIAL (63739-170-13) |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | INJECTABLE;INJECTION | 212821 | ANDA | McKesson Corporation dba SKY Packaging | 63739-170 | 63739-170-27 | 25 VIAL in 1 BOX (63739-170-27) / 5 mL in 1 VIAL (63739-170-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1% | ||||
Approval Date: | May 7, 2020 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 2% | ||||
Approval Date: | Jun 15, 2023 | TE: | AP | RLD: | No |
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