Details for New Drug Application (NDA): 216250
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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 216250
Tradename: | LIDOCAINE HYDROCHLORIDE |
Applicant: | Novitium Pharma |
Ingredient: | lidocaine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216250
Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 216250
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;TOPICAL | 216250 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-736 | 10135-736-51 | 1 BOTTLE in 1 CARTON (10135-736-51) / 50 mL in 1 BOTTLE |
LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;TOPICAL | 216250 | ANDA | Novitium Pharma LLC | 70954-518 | 70954-518-10 | 1 BOTTLE in 1 CARTON (70954-518-10) / 50 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 4% | ||||
Approval Date: | Mar 23, 2022 | TE: | AT | RLD: | No |
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