To Declare that Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg are Suitable for Submission as an Abbreviated New Drug Application - CLOSED

 
Docket ID: FDA-2011-P-0302
Agency: Food and Drug Administration (FDA)
Parent Agency: Department of Health and Human Services (HHS)
Summary:
Status: Closed
Docket Details open glossary dialog  
Related RINs: None
Related Dockets: None
Short Title: To Declare that Hydrocodone Bitartrate and Acetaminophen Effervescent Tablets are Suitable for Submission as an Abbreviated New Drug Application
Keyword(s): Hydrocodone, Bitartrate, Acetaminophen, Tablets, CDER, CLOSED
Type: Nonrulemaking
Docket Status: CLOSED
Center: CDER
Docket Item Code: P
 

Primary Documents

View All  (4)
Comment Period Closed
Other
Posted: 08/10/2012
ID: FDA-2011-P-0302-0004
Comment Period Closed
Other
Posted: 05/25/2011
ID: FDA-2011-P-0302-0003
Comment Period Closed
Other
Posted: 05/25/2011
ID: FDA-2011-P-0302-0002
Other
Posted: 05/25/2011
ID: FDA-2011-P-0302-0001

Supporting Documents

 
No documents available.

Comments

 
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1
Comments Received*
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