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Generated: November 15, 2018

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Details for New Drug Application (NDA): 208791

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NDA 208791 describes CLOROTEKAL, which is a drug marketed by B Braun Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CLOROTEKAL profile page.

The generic ingredient in CLOROTEKAL is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
Summary for 208791
Tradename:CLOROTEKAL
Applicant:B Braun Medical Inc
Ingredient:chloroprocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208791
Ingredient-typeEsters
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 208791
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOROTEKAL chloroprocaine hydrochloride SOLUTION;INTRATHECAL 208791 NDA B. Braun Medical Inc. 0264-7055 0264-7055-10 10 AMPULE in 1 CARTON (0264-7055-10) > 5 mL in 1 AMPULE (0264-7055-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRATHECALStrength50MG/5ML (10MG/ML)
Approval Date:Sep 26, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 26, 2020
Regulatory Exclusivity Use:NEW PRODUCT

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