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ROMAZICON (nda020073)- (0.5MG/5ML (0.1MG/ML),1MG/10ML (0.1MG/ML))

FLUMAZENIL HOFFMANN LA ROCHE
0.5MG/5ML (0.1MG/ML),1MG/10ML (0.1MG/ML)
No No
2004-Oct-10 Expired
None None
None No
ROMAZICON is indicated (Adult patients) for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose. ROMAZICON (Pediatric patients) is indicated for the reversal of conscious sedation induced with benzodiazepines.
8 0 3
Total Other Developers None
Drugs with Suitability No
0.5MG/5ML (0.1MG/ML) ** ** - - 3
1MG/10ML (0.1MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 3
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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