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Details for New Drug Application (NDA): 086283
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NDA 086283 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Akorn, Am Regent, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Cosette, Watson Labs Inc, Hi Tech Pharma, Wockhardt Bio Ag, Hikma, Lannett Co Inc, Paco, Teligent Pharma Inc, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, and Actavis Mid Atlantic, and is included in ninety-seven NDAs. It is available from twenty-nine suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 086283
| Tradename: | LIDOCAINE HYDROCHLORIDE |
| Applicant: | Intl Medication |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 086283
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 086283
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | JELLY;TOPICAL | 086283 | ANDA | A-S Medication Solutions | 50090-4538 | 50090-4538-0 | 20 mL in 1 VIAL, SINGLE-USE (50090-4538-0) |
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | JELLY;TOPICAL | 086283 | ANDA | A-S Medication Solutions | 50090-4554 | 50090-4554-0 | 10 mL in 1 VIAL, SINGLE-USE (50090-4554-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | JELLY;TOPICAL | Strength | 2% | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AT | RLD: | No | ||||
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