Determine That Pfizer's Antivert® Chewable Tablets 25 mg was not Discontinued for Safety and Efficacy Reason and re List InvaGen's Meclizine Hydrochloride Chewable Tablets, 25 mg

 
Docket ID: FDA-2011-P-0047
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: Determine That Pfizer's Antivert® Chewable Tablets 25 mg was not Discontinued for Safety and Efficacy Reason and re List InvaGen's Meclizine Hydrochloride Chewable Tablets, 25 mg
Keyword(s): cder, meclizine hydrochloride, chewable table, 25mg, antivert oral tablets, open
Type: Nonrulemaking
Docket Status: OPEN
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (4)
Comment Now!
Due Jan 18, 2011 11:59 PM ET
Other
Posted: 02/08/2011
ID: FDA-2011-P-0047-0001
Comment Period Closed
Other
Posted: 07/21/2011
ID: FDA-2011-P-0047-0012
Comment Period Closed
Other
Posted: 03/09/2011
ID: FDA-2011-P-0047-0007
Comment Period Closed
Other
Posted: 02/08/2011
ID: FDA-2011-P-0047-0006

Supporting Documents

View All  (8)
Comments Not Accepted
Supporting & Related Material
Posted: 03/09/2011
ID: FDA-2011-P-0047-0009
Comments Not Accepted
Supporting & Related Material
Posted: 03/09/2011
ID: FDA-2011-P-0047-0011
Comments Not Accepted
Supporting & Related Material
Posted: 03/09/2011
ID: FDA-2011-P-0047-0010

Comments

 
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