Declare That the Drug Products, Metformin Hydrochloride Chewable Tables, 500 mg, 850 mg, and 1 g are Suitable for Consideration in an Abbreviated New Drug Application (ANADA) - CLOSED

 
Docket ID: FDA-2011-P-0558
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: Declare That the Drug Products, Metformin Hydrochloride Chewable Tables, 500 mg, 850 mg, and 1 g are Suitable for Consideration in an Abbreviated New Drug Application (ANADA)
Keyword(s): NDA 20-357, 500 mg, 1 g, 850 mg, metformin hydrochloride, chewable tablets, glucophage, dysphasia, closed
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (3)
Comment Period Closed
Sep 26, 2011 11:59 PM ET
Other
Posted: 08/08/2011
ID: FDA-2011-P-0558-0001
Comment Period Closed
Other
Posted: 10/18/2012
ID: FDA-2011-P-0558-0003
Comment Period Closed
Other
Posted: 08/08/2011
ID: FDA-2011-P-0558-0002

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