| Up
2005P-0300:
Determine That the Drug Phenergan (promethazine hydrochloride) 12.5
mg and 50 mg Tablets (NDA 07-935) Was Voluntarily Withdrawn From
Sale for Reasons Other Than Safety or Effectiveness
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| CP1
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| 07/29/2005
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| 07/29/2005
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| Drug Industry
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| Amide Pharmaceutical,
Inc.
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| pdf
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| Signature:
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| Jasmine Shah, M.S., R.Ph.
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| ACK1
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| 07/29/2005
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| 07/29/2005
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| Federal Government
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| HFA-305 to Amide Pharmaceutical,
Inc.
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| LET1
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| 01/27/2006
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| 01/27/2006
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| Federal Government
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| HFD-005 to Amide Pharmaceutical,
Inc.
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| pdf
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| Signature:
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| Jane A. Axelrad
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| N1
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| 07/13/2006
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| FDA
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| FDA
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| 07/14/2006
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| 40129-40130
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| txt
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| Signature:
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| SHUREN, JEFFREY
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| N2
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| 07/13/2006
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| FDA
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| Number not used
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| 07/14/2006
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| 40129-40130
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| Signature:
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| SHUREN, JEFFREY
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| LET2
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| 07/18/2006
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| 07/18/2006
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| Federal Government
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| FDA/CDER to Amide
Pharmaceutical, Inc.
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| pdf
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| Signature:
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| Quynh H. Nguyen
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Top | Up
Page last updated
August 11, 2006
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