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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 088803

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NDA 088803 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, Wockhardt Bio Ag, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Taro, The J Molner, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Actavis Mid Atlantic, and Chartwell Molecular, and is included in one hundred and nine NDAs. It is available from forty 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.

Summary for 088803

Tradename:	LIDOCAINE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	lidocaine hydrochloride
Patents:	0

Pharmacology for NDA: 088803

Physiological Effect	Local Anesthesia

Suppliers and Packaging for NDA: 088803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	SOLUTION;TOPICAL	088803	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3505	0054-3505-47	50 mL in 1 BOTTLE (0054-3505-47)
LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	SOLUTION;TOPICAL	088803	ANDA	Golden State Medical Supply, Inc.	51407-825	51407-825-50	50 mL in 1 BOTTLE (51407-825-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	4%
Approval Date:	Apr 3, 1985	TE:	AT	RLD:	No

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