Details for New Drug Application (NDA): 209190
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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 209190
Tradename: | LIDOCAINE |
Applicant: | Ibsa |
Ingredient: | lidocaine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209190
Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 209190
Suppliers and Packaging for NDA: 209190
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | lidocaine | PATCH;TOPICAL | 209190 | ANDA | PURETEK CORPORATION | 59088-905 | 59088-905-54 | 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) |
LIDOCAINE | lidocaine | PATCH;TOPICAL | 209190 | ANDA | PURETEK CORPORATION | 59088-907 | 59088-907-54 | 30 POUCH in 1 PACKAGE (59088-907-54) / 1 PATCH in 1 POUCH (59088-907-84) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | PATCH;TOPICAL | Strength | 5% | ||||
Approval Date: | Apr 30, 2020 | TE: | AB | RLD: | No |
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