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Details for New Drug Application (NDA): 206498
NDA 206498 describes LIDOCAINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Riconpharma Llc, Septodont Inc, Taro, Teligent Pharma Inc, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Fougera Pharms, Hi Tech Pharma, Tolmar, Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Luitpold Pharms Inc, Lyphomed, Miles, Mylan Labs Ltd, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, G And W Labs Inc, Watson Labs Inc, Wockhardt Bio Ag, Paco, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in one hundred and eleven NDAs. It is available from thirty-two suppliers. Additional details are available on the LIDOCAINE profile page.
The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen 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.
The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen 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 206498
| Tradename: | LIDOCAINE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | lidocaine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206498
| Ingredient-type | Amides |
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 206498
Suppliers and Packaging for NDA: 206498
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 206498 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-418 | N | 68462-418-20 |
| LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 206498 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-418 | N | 68462-418-27 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
| Approval Date: | Sep 9, 2016 | TE: | AT | RLD: | No | ||||
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