Details for New Drug Application (NDA): 210958
NDA 210958 describes LIDOCAINE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Belmora Llc, Chartwell Rx, Cosette Pharms Nc, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, H2-pharma, Macleods Pharms, Quagen, Rising, Septodont Inc, Strides Pharma, Sun Pharma Canada, Teva Pharms Usa, Actavis Labs Ut Inc, Amneal, Difgen Pharms, Ibsa, Invagen Pharms, Nal Pharm, Noven Pharms Inc, Pharmobedient, Fougera Pharms, Hikma, Padagis Us, Pai Holdings Pharm, Zydus Lifesciences, Abbott, Abraxis Pharm, Adaptis, Am Regent, Aspiro, B Braun Medical, Bel Mar, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Heritage, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Spectra Mdcl Devices, Viwit Pharm, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Sentiss, Watson Labs Inc, Rubicon Research, Lannett Co Inc, Novitium Pharma, Paco, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and fifty NDAs. It is available from forty-two suppliers. Additional details are available on the LIDOCAINE profile page.
The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are four drug master file entries for this compound. Twelve 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 four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 210958
| Tradename: | LIDOCAINE |
| Applicant: | Strides Pharma |
| Ingredient: | lidocaine |
| Patents: | 0 |
Pharmacology for NDA: 210958
| Physiological Effect | Local Anesthesia |
Medical Subject Heading (MeSH) Categories for 210958
Suppliers and Packaging for NDA: 210958
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 210958 | ANDA | Proficient Rx LP | 71205-814 | 71205-814-44 | 35.44 g in 1 TUBE (71205-814-44) |
| LIDOCAINE | lidocaine | OINTMENT;TOPICAL | 210958 | ANDA | Proficient Rx LP | 71205-814 | 71205-814-52 | 8 TUBE in 1 CARTON (71205-814-52) / 35.44 g in 1 TUBE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | OINTMENT;TOPICAL | Strength | 5% | ||||
| Approval Date: | Dec 11, 2018 | TE: | AT | RLD: | No | ||||
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