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Details for New Drug Application (NDA): 202242

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NDA 202242 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Intl Medication, Roxane, Graham Chem, Eurohlth Intl Sarl, Abraxis Pharm, Bel Mar, Vintage, Hospira, Miles, Hi Tech Pharma, G And W Labs Inc, Elkins Sinn, Watson Labs, Akorn, Gd Searle Llc, Watson Labs Inc, Mylan Labs Ltd, Luitpold, Abbott, Luitpold Pharms Inc, Wockhardt, Wyeth Ayerst, Dell Labs, Paco, Lyphomed, Teligent Pharma Inc, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Actavis Mid Atlantic, and is included in ninety-three NDAs. It is available from thirty-four suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are seventeen 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 NDA: 202242

Mylan Labs Ltd
lidocaine hydrochloride
Therapeutic Class:Anesthetics

Pharmacology for NDA: 202242

Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 202242

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
lidocaine hydrochloride
INJECTABLE;INJECTION 202242 ANDA AGILA SPECIALTIES PRIVATE LIMITED 76126-041 76126-041-20 25 VIAL in 1 CARTON (76126-041-20) > 20 mL in 1 VIAL
lidocaine hydrochloride
INJECTABLE;INJECTION 202242 ANDA AGILA SPECIALTIES PRIVATE LIMITED 76126-041 76126-041-50 25 VIAL in 1 CARTON (76126-041-50) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Apr 11, 2014TE:APRLD:No

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