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2006P-0469: Declare that a New Drug Application for Ibuprofen Potassium 200 mg Phenylephine Hydrochloride 10 mg Capsules is Suitable for Submission as an Abbreviated New Drug Application, Pursuant to 21 CFR 314.94
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
CP1 11/20/2006 11/20/2006 Private Industry Strides Inc.       Table of Contents  
Signature: Nehru Gaddipati, PhD, RPh
ACK1 11/20/2006 11/20/2006 Federal Government FDA/DDM to Strides Inc.       pdf  
Signature: Lyle D. Jaffe

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Page last updated November 28, 2006 kkhorizonal rule
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