Determine that Fexofenadine HCI Oral Suspension, 15 mg/2.5mL (6 mg/mL) and 15mg/5mL ( 3 mg/mL) are Suitable for Submission in an Abbreviated New Drug Application (ANDA) - CLOSED

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Docket ID : FDA-2010-P-0231
Agency : Food and Drug Administration (FDA)
Parent Agency : Department of Health and Human Services (HHS)
Summary :
Status: CLOSED
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Related RINs: None
Related Dockets: None
Docket Item Code: P
Type: Nonrulemaking
Center: CDER
Short Title: Determine that Fexofenadine HCI Oral Suspension, 15 mg/2.5mL (6 mg/mL) and 15mg/5mL ( 3 mg/mL) are Suitable for Submission in an ANDA
Keyword(s): fexofenadine HCI, 15mg/2.5mL, 6mg/mL, allerga, 21-963, oral suspension, CDER, closed
Docket Status: CLOSED
 
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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.