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. There are two patents protecting this drug. 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. Six suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.
The generic ingredient in CLOROTEKAL is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Six 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: | 2 |
Pharmacology for NDA: 208791
| Physiological Effect | Local 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: | DISCN | Dosage: | SOLUTION;INTRATHECAL | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Sep 26, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR INDUCING A REGIONAL ANAESTHESIA VIA INTRATHECAL ADMINISTRATION OF A PATENTED PRESERVATIVE FREE SOLUTION FOR INJECTION (WITH A SPECIFIC COMPOSITION, PH, OSMOLALITY AND DENSITY) CONTAINING 9-11 MG/ML CHLOROPROCAINE HCL | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 11, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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