Details for New Drug Application (NDA): 206297
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The generic ingredient in LIDOCAINE 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 206297
Tradename: | LIDOCAINE |
Applicant: | Amneal Pharms |
Ingredient: | lidocaine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206297
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 206297
Suppliers and Packaging for NDA: 206297
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 206297 | ANDA | medsource pharmaceuticals | 45865-950 | 45865-950-01 | 50 g in 1 JAR (45865-950-01) |
LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 206297 | ANDA | Amneal Pharmaceuticals LLC | 65162-918 | 65162-918-41 | 150 g in 1 JAR (65162-918-41) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
Approval Date: | Aug 7, 2015 | TE: | AT | RLD: | No |
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