Details for New Drug Application (NDA): 040014
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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. Ten suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 040014
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | Hikma |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040014
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 040014
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;ORAL | 040014 | ANDA | A-S Medication Solutions | 50090-0255 | 50090-0255-0 | 100 mL in 1 BOTTLE, PLASTIC (50090-0255-0) |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;ORAL | 040014 | ANDA | Akorn | 50383-363 | 50383-363-17 | 4 TRAY in 1 CASE (50383-363-17) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (50383-363-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 2% | ||||
Approval Date: | Jul 10, 1995 | TE: | RLD: | No |
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