Details for New Drug Application (NDA): 202346
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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 202346
Tradename: | LIDOCAINE |
Applicant: | Mylan Technologies |
Ingredient: | lidocaine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202346
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 202346
Suppliers and Packaging for NDA: 202346
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | lidocaine | PATCH;TOPICAL | 202346 | ANDA | Mylan Pharmaceuticals Inc. | 0378-9055 | 0378-9055-93 | 30 POUCH in 1 CARTON (0378-9055-93) / 1 PATCH in 1 POUCH (0378-9055-16) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | PATCH;TOPICAL | Strength | 5% | ||||
Approval Date: | Aug 7, 2015 | TE: | AB | RLD: | No |
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