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1997N-0314: Prescription Drug Products; Levothyroxine Sodium
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
N1   08/13/1997 FDA FDA     10/14/1997 pdf EFF: 8/14/97
Signature: FDA
LET1 09/24/1997 09/24/1997 Private Industry Knoll Pharmaceutical Co.       pdf  
Signature: Jane E. Baluss, Buc & Beardsley
CP1 10/14/1997 10/15/1997 Association Mason,Taylor & Colicchio       pdf ACK 10/15/97
Signature: Robert A. Boutillier
ANS1 10/14/1997 10/09/1997 Other Organization HFD-7       pdf SEE LET1
Signature: Jane A. Axelrad
CP2 12/15/1997 12/15/1997 Private Industry Knoll Pharmaceutical Co       Copyrighted Material ACK 12/15/97
Signature: Stevn J Goldberg, et.al(Buck&Beards
LET2 04/15/1998 04/15/1998 Other Organization HFC-1 to Mason, Taylor & Colicchio       pdf INT. 4/9/98
Signature: Ronald G. Chesemore
SUP1 05/29/1998 05/29/1998 Private Industry Knoll Pharmaceutical Co.       pdf 2 VOLS SEE CP2
Signature: Jane Baluss (Buc & Beardsley)
LET3 06/16/1998 06/16/1998 Private Industry Jones Medical Ind.       pdf  
Signature: Jess H. Stribling (King & Spalding)
CP3 09/25/1998 09/25/1998 Private Industry Knoll Pharmaceutical Company       pdf  
Signature: Gary D. Dolch, Ph.D et al
ACK1 09/25/1998 09/25/1998 Other Organization HFA-305       pdf  
Signature: Jennie Butler
LET4 03/15/1999 03/15/1999 Private Industry Knoll Pharmaceutical Co.       pdf  
Signature: Nancy L. Buc (Buc & Beardsley)
C1 03/18/1999 03/18/1999 Private Industry Jones Pharma Inc.       pdf  
Signature: David F. Weeda (Olsson, Frank & Wee
ANS2 05/04/1999 05/04/1999 Other Organization HFD-5 to Nancy L Buc, Buc & Beardsley       pdf SEE LET 4
Signature: Jane A Axelrad
SUP2 08/04/1999 08/04/1999 Private Industry Knoll Pharmaceutical Co.       pdf, Copyrighted Material VOL 1 OF 1
Signature: Gary Dolch, Ph.D. & Melvin Spigelman
C2 10/12/1999 10/06/1999 Private Industry King & Spalding       pdf  
Signature: Jess H. Stribling
SUP3 11/09/1999 11/09/1999 Private Industry Knoll Pharmaceutical Company       pdf  
Signature: Gary D. Dolch, Ph.D et al
SUP4 11/17/1999 11/17/1999 Private Industry Knoll Pharmaceutical Co.       pdf SEE CP2
Signature: Gary Dolch, Ph.D. & Melvin Spigelman
N2   04/25/2000 FDA FDA       pdf EFF 4/26/2000
Signature: FDA
PAV1 05/01/2000 05/01/2000 Other Organization HFC-1 to Knoll Pharmaceutical Co.       pdf DENIED IN PART DTD 4/26/00
Signature: Dennis E. Baker
LET5 05/05/2000 04/28/2000 Private Industry Knoll Pharmaceutical Company       pdf  
Signature: Nancy L. Buc (Buc & Beardsley)
LET6 05/05/2000 04/28/2000 Private Industry Knoll Pharmaceutical Coompany       pdf  
Signature: Nancy L. Buc (Buc & Beardsley)
CP4 11/22/1999 11/24/2000 Private Industry Jerome Stevens Pharmaceuticals Inc       pdf ACK 11/27/00
Signature: Marc J Scheineson, Esq, Reed Smith
ACK2 11/27/2000 11/27/2000 Other Organization HFA-305       pdf  
Signature: Jennie Butler
SUP5 12/18/2000 12/18/2000 Private Industry Knoll Pharmaceutical Company       pdf, Copyrighted Material SEE CP2
Signature: Gary Dolch PhD & Melvin Spigelman
PDN1 02/08/2001 02/08/2001 Other Organization HFC-1 to Jerome Stevens Pharmaceutical       pdf SEE CP4
Signature: Dennis E Baker
PDN2 04/27/2001 04/27/2001 Other Organization HFC-1 to Knoll Pharmaceutical Company       pdf SEE CP2 (CLOSEDDTD 4/26/01
Signature: Dennis E Baker
PDN3 05/04/2001 05/04/2001 Other Organization HFC-1 to Mason, Taylor & Colicchio       pdf SEE CP1 (CLOSEDDTD 4/46/01
Signature: Dennis E. Baker
EMC1 06/04/2001 06/04/2001 Individual Consumer Wendi Adams        
EMC2 06/04/2001 06/02/2001 Association Connecticut Endocrine Society       pdf  
Signature: William A Petit Jr MD
EMC3 06/04/2001 06/01/2001 Individual Consumer ALDJ        
EMC4 06/01/2001 06/01/2001 Individual Consumer O R Jordan        
C3 06/11/2001 06/11/2001 Private Industry Jerome Stevens Pharmaceuitical Inc       pdf  
Signature: Stuart M Pape, Patton Boggs
ANS3 06/11/2001 06/11/2001 Other Organization HFD-5 to Patton Boggs       pdf SEE C3
Signature: Jane A Axelrad
EMC5 06/28/2001 06/28/2001 Individual Consumer Theodore R Frimet        
EMC6 07/10/2001 07/10/2001 Individual Consumer Sarah Schwartz        
EC1 07/14/2001 07/13/2001 Individual Consumer Mr. Mark MacInnes        
EC2 07/14/2001 07/13/2001 Individual Consumer Mrs. EDYTHE SANDS        
EC3 07/17/2001 07/16/2001 Individual Consumer Mr. Jay Ter Louw        
EC4 07/17/2001 07/16/2001 Individual Consumer Dr. Arthur Goldwyn        
GDL1 07/11/2001 07/18/2001 Legacy GUIDANCE       pdf  
Signature: GUIDANCE
NAD1   07/12/2001 FDA FDA       pdf  
Signature: FDA
C4 07/24/2001 07/18/2001 Individual Consumer Edy Rudnick Pineless        
EMC7 07/13/2001 07/13/2001 Individual Consumer Jennifer Sellman SrA USAF        
EMC8 07/16/2001 07/14/2001 Individual Consumer Donald F Figliola Jr MD        
EMC9 07/16/2001 07/16/2001 Individual Consumer Thomas J Taylor MD        
EMC10 07/17/2001 07/17/2001 Individual Consumer Edy Rudnick Pineless        
EMC11 07/17/2001 07/17/2001 Individual Consumer Gloria Beliveau        
EC5 07/18/2001 07/17/2001 Individual Consumer Mr. Richard Vitale        
EC6 07/18/2001 07/17/2001 Individual Consumer Ms. Jane La Barbera        
EC7 07/19/2001 07/18/2001 Individual Consumer Mr. Fredric Baumann        
EC8 07/24/2001 07/23/2001 Individual Consumer Private Citizen        
EC9 07/27/2001 07/26/2001 Individual Consumer Mrs. Bonnie Leister        
EC10 08/04/2001 08/03/2001 Individual Consumer Univera Healthcare        
EC11 01/19/2002 01/18/2002 Individual Consumer Dr. RASHMIN PUROHIT        
EC12 07/01/2002 06/30/2002 Individual Consumer Ms. Reseda Mickey        

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