Determine that Dexmedetomidine Hydrochloride Injection in a 400mcg/4mL Vial Suitable for Submission as an Abbreviated New Drug Application (ANDA)

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Docket ID : FDA-2012-P-1147
Agency : Food and Drug Administration (FDA)
Parent Agency : Department of Health and Human Services (HHS)
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Related RINs: None
Related Dockets: None
Docket Item Code: P
Type: Nonrulemaking
Center: CDER
Legacy ID: 2012-9277
Short Title: Determine that Dexmedetomidine Hydrochloride Injection in a 400mcg/4mL Vial Suitable as an ANDA
Keyword(s): cder, anda, 2012-9277, dexmedetomidine hydrochloride, injection, 400mcg/4mL, vial, rld, precedex, sodium chloride , intensive care unit, sedation, open
Docket Status: OPEN
 
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Comments Received *
* The total reflects comments received from Regulations.gov and other means as of 11:59 PM yesterday. All comments received may not be posted at this time including bulk submissions; therefore, the total comments received and posted may differ.