Details for New Drug Application (NDA): 216780
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NDA 216780 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Rising, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Cosette, Sentiss, Watson Labs Inc, Hikma, Rubicon, Xttrium Labs Inc, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Taro, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Extrovis, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and nine NDAs. It is available from forty-two 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 216780
| Tradename: | LIDOCAINE HYDROCHLORIDE |
| Applicant: | Rubicon |
| Ingredient: | lidocaine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216780
| Physiological Effect | Local Anesthesia |
Suppliers and Packaging for NDA: 216780
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;ORAL | 216780 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0138 | 17856-0138-1 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-1) / 15 mL in 1 CUP, UNIT-DOSE (17856-0138-3) |
| LIDOCAINE HYDROCHLORIDE | lidocaine hydrochloride | SOLUTION;ORAL | 216780 | ANDA | ATLANTIC BIOLOGICALS CORP. | 17856-0138 | 17856-0138-2 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0138-2) / 20 mL in 1 CUP, UNIT-DOSE (17856-0138-4) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 2% | ||||
| Approval Date: | Mar 28, 2023 | TE: | AT | RLD: | No | ||||
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