Details for New Drug Application (NDA): 208791
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NDA 208791 describes CLOROTEKAL, which is a drug marketed by B Braun Medical and is included in one NDA. 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 |
| Ingredient: | chloroprocaine hydrochloride |
| Patents: | 2 |
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: | 8,969,412 | 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: | 9,504,666 | Patent Expiration: | Dec 11, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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