| | | | | | | | | | |
|
|
| Dockets Entered
On June 8, 2007
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
| 2007P-0224
|
| ANDA Suitability Petition for NDA 21-774 Ambien CR (Zolpidem tartrate)
|
|
|
| 2007P-0226
|
| to permit an ANDA suitability for Donepezil Hydrochloride Orally Dissolving Film Stripps, 5 mg and 10 mg
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET 19920
|
| Enzyme Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19921
|
| Enzyme Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19922
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19923
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19924
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19925
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19926
|
| Alltech, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19927
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19928
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19929
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19930
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19931
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19932
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19933
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19934
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19935
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19936
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19937
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19938
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19939
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19940
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19941
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19942
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19943
|
| NBTY Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19944
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
| | | | | | | |
|
|
| LET 19945
|
| Eu Yan Sang (Hong Kong) Limited
|
| Vol #:
|
| 175
|
|
|
| LET 19946
|
| Univera LifeSciences, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19947
|
| Source Naturals
|
| Vol #:
|
| 175
|
|
|
| LET 19948
|
| Source Naturals
|
| Vol #:
|
| 175
|
|
|
| LET 19949
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19950
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19951
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19952
|
| Enzymatic Therapy, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19953
|
| Phytosolution Nutraceutical Systems llc
|
| Vol #:
|
| 175
|
|
|
| LET 19954
|
| Phytosolution Nutraceutical Systems llc
|
| Vol #:
|
| 175
|
|
|
| LET 19955
|
| Phytosolution Nutraceutical Systems llc
|
| Vol #:
|
| 175
|
|
|
| LET 19956
|
| Phytosolution Nutraceutical Systems llc
|
| Vol #:
|
| 175
|
|
|
| LET 19957
|
| Phytosolution Nutraceutical Systems llc
|
| Vol #:
|
| 175
|
|
|
| LET 19958
|
| Taisho Pharmaceutical CA, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19959
|
| Eu Yan Sang (Hong Kong) Limited
|
| Vol #:
|
| 175
|
|
|
| LET 19960
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19961
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19962
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19963
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19964
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19965
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19966
|
| HERB PHARM
|
| Vol #:
|
| 175
|
|
|
| LET 19967
|
| AdvoCare
|
| Vol #:
|
| 175
|
|
|
| LET 19968
|
| Sante' Active, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19969
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19970
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19971
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19972
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19973
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19974
|
| EQUAVIE
|
| Vol #:
|
| 175
|
|
|
| LET 19975
|
| Chenko Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19976
|
| NBTY
|
| Vol #:
|
| 175
|
|
|
| LET 19977
|
| NBTY
|
| Vol #:
|
| 175
|
|
|
| LET 19978
|
| Pure Encapsulations
|
| Vol #:
|
| 175
|
|
|
| LET 19979
|
| Source Naturals
|
| Vol #:
|
| 175
|
|
|
| LET 19980
|
| Taisho Pharmaceutical CA, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19981
|
| Orenda Internatyional, LLC
|
| Vol #:
|
| 175
|
|
| | | | | | | | |
|
|
| LET 19982
|
| CardioTabs, Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19983
|
| Orenda International, LLC
|
| Vol #:
|
| 175
|
|
|
| LET 19984
|
| ChildLife
|
| Vol #:
|
| 175
|
|
|
| LET 19985
|
| Pfantastic Medical Research Institute, LLC
|
| Vol #:
|
| 175
|
|
|
| LET 19986
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19987
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19988
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19989
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19990
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19991
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19992
|
| Boots Retail USA Inc.
|
| Vol #:
|
| 175
|
|
|
| LET 19993
|
| Enzymatic Therapy Inc.
|
| Vol #:
|
| 175
|
|
|
| 2003N-0573
|
| Draft Animal Cloning Risk Assessment
|
|
|
| C 1334
|
| J. Ungar
|
| Vol #:
|
| 68
|
|
|
| C 1335
|
| P. Crane
|
| Vol #:
|
| 68
|
|
|
| C 1336
|
| N. Gordon
|
| Vol #:
|
| 68
|
|
|
| C 1337
|
| R. Garcia
|
| Vol #:
|
| 68
|
|
|
| C 1338
|
| L. Graham
|
| Vol #:
|
| 68
|
|
|
| C 1339
|
| B. Wardle
|
| Vol #:
|
| 68
|
|
|
| C 1340
|
| T. Christon
|
| Vol #:
|
| 68
|
|
|
| C 1341
|
| C. Camp
|
| Vol #:
|
| 68
|
|
|
| C 1342
|
| S. Mehrotra
|
| Vol #:
|
| 68
|
|
|
| C 1343
|
| M. Wade
|
| Vol #:
|
| 68
|
|
|
| C 1344
|
| P. Stone
|
| Vol #:
|
| 68
|
|
|
| C 1345
|
| M. Guenther
|
| Vol #:
|
| 68
|
|
|
| C 1346
|
| M. Lovato
|
| Vol #:
|
| 68
|
|
|
| C 1347
|
| J. Julien
|
| Vol #:
|
| 68
|
|
|
| C 1348
|
| J. Halloran
|
| Vol #:
|
| 68
|
|
|
| C 1349
|
| J. Tessmer
|
| Vol #:
|
| 68
|
|
|
| C 1350
|
| L. Wikstrom
|
| Vol #:
|
| 68
|
|
|
| C 1351
|
| E. Smith
|
| Vol #:
|
| 68
|
|
|
| C 1352
|
| T. Peralta
|
| Vol #:
|
| 68
|
|
|
| C 1353
|
| S. McDonald
|
| Vol #:
|
| 68
|
|
|
| C 1354
|
| M. Converse
|
| Vol #:
|
| 68
|
|
|
| C 1355
|
| M. Ventrella
|
| Vol #:
|
| 68
|
|
|
| C 1356
|
| K. Grag
|
| Vol #:
|
| 68
|
|
| | | | | | | |
|
|
| C 1357
|
| M. Steele
|
| Vol #:
|
| 68
|
|
|
| C 1358
|
| J. Otto
|
| Vol #:
|
| 68
|
|
|
| C 1359
|
| M. Shanahan
|
| Vol #:
|
| 68
|
|
|
| C 1360
|
| N. Polsue
|
| Vol #:
|
| 68
|
|
|
| C 1361
|
| M. Genoa
|
| Vol #:
|
| 68
|
|
|
| C 1362
|
| S. Camp
|
| Vol #:
|
| 68
|
|
|
| C 1363
|
| K. Oda
|
| Vol #:
|
| 68
|
|
|
| C 1364
|
| L. Pucci
|
| Vol #:
|
| 68
|
|
|
| C 1365
|
| C. Thiel
|
| Vol #:
|
| 68
|
|
|
| C 1366
|
| V. Fong
|
| Vol #:
|
| 68
|
|
|
| C 1367
|
| S. McNamara
|
| Vol #:
|
| 68
|
|
|
| C 1368
|
| M. Bronsnan
|
| Vol #:
|
| 68
|
|
|
| C 1369
|
| T. Barney
|
| Vol #:
|
| 68
|
|
|
| C 1370
|
| T. Schuster
|
| Vol #:
|
| 68
|
|
|
| C 1371
|
| S. Bolar
|
| Vol #:
|
| 68
|
|
|
| C 1372
|
| T. Cafferty
|
| Vol #:
|
| 68
|
|
|
| C 1373
|
| R. Steinfurth
|
| Vol #:
|
| 68
|
|
|
| C 1374
|
| L. Vavrick
|
| Vol #:
|
| 68
|
|
|
| C 1375
|
| V. Sawyer
|
| Vol #:
|
| 68
|
|
|
| C 1376
|
| S. Guerrero
|
| Vol #:
|
| 68
|
|
|
| C 1377
|
| E. Boyd
|
| Vol #:
|
| 68
|
|
|
| C 1378
|
| R. Schroeter
|
| Vol #:
|
| 68
|
|
|
| C 1379
|
| A. Klein
|
| Vol #:
|
| 68
|
|
|
| C 1380
|
| O. Bielawski
|
| Vol #:
|
| 68
|
|
|
| C 1381
|
| L. Deets
|
| Vol #:
|
| 68
|
|
|
| C 1382
|
| L. Deets
|
| Vol #:
|
| 68
|
|
|
| C 1383
|
| R. Anderlik
|
| Vol #:
|
| 68
|
|
|
| C 1384
|
| M. Gordon
|
| Vol #:
|
| 68
|
|
|
| C 1385
|
| J. Turner
|
| Vol #:
|
| 68
|
|
|
| C 1386
|
| N. Andresen
|
| Vol #:
|
| 68
|
|
|
| C 1387
|
| J. Filip
|
| Vol #:
|
| 68
|
|
|
| C 1388
|
| C. Wolfe
|
| Vol #:
|
| 68
|
|
|
| C 1389
|
| M. Mangiarelli
|
| Vol #:
|
| 68
|
|
|
| C 1390
|
| C. Johnson
|
| Vol #:
|
| 68
|
|
|
| C 1391
|
| D. Silverman
|
| Vol #:
|
| 68
|
|
|
| C 1392
|
| L. Doleshal
|
| Vol #:
|
| 68
|
|
|
| C 1393
|
| J. Shore
|
| Vol #:
|
| 68
|
|
| | | | | | | |
|
|
| C 1394
|
| J. Lester
|
| Vol #:
|
| 68
|
|
|
| C 1395
|
| D. Iregui
|
| Vol #:
|
| 68
|
|
|
| C 1396
|
| D. Jankowski
|
| Vol #:
|
| 68
|
|
|
| C 1397
|
| M. Argo
|
| Vol #:
|
| 68
|
|
|
| C 1398
|
| Y. Silva
|
| Vol #:
|
| 68
|
|
|
| C 1399
|
| M. Gilbert
|
| Vol #:
|
| 68
|
|
|
| C 1400
|
| L. Franks
|
| Vol #:
|
| 68
|
|
|
| C 1401
|
| N. Procopio
|
| Vol #:
|
| 68
|
|
|
| C 1402
|
| S. Johnson
|
| Vol #:
|
| 68
|
|
|
| C 1403
|
| C. Huleva
|
| Vol #:
|
| 68
|
|
|
| C 1404
|
| A. Dellago
|
| Vol #:
|
| 68
|
|
|
| C 1405
|
| K. Marin
|
| Vol #:
|
| 68
|
|
|
| C 1406
|
| M. McDonald
|
| Vol #:
|
| 68
|
|
|
| C 1407
|
| C. Madden
|
| Vol #:
|
| 68
|
|
|
| C 1408
|
| T. Hicks
|
| Vol #:
|
| 68
|
|
|
| C 1409
|
| G. Haley
|
| Vol #:
|
| 68
|
|
|
| C 1410
|
| L. Hamblin
|
| Vol #:
|
| 68
|
|
|
| C 1411
|
| K. Genetive
|
| Vol #:
|
| 68
|
|
|
| C 1412
|
| M. Neilsen
|
| Vol #:
|
| 68
|
|
|
| C 1413
|
| P. Gerresheim
|
| Vol #:
|
| 68
|
|
|
| C 1414
|
| A. Cabada
|
| Vol #:
|
| 68
|
|
|
| C 1415
|
| M. Lasater
|
| Vol #:
|
| 68
|
|
|
| C 1416
|
| M. Aitken
|
| Vol #:
|
| 68
|
|
|
| C 1417
|
| L. Wells
|
| Vol #:
|
| 68
|
|
|
| C 1418
|
| J. Martin
|
| Vol #:
|
| 68
|
|
|
| C 1419
|
| T. Newman
|
| Vol #:
|
| 68
|
|
|
| C 1420
|
| A. Drechaler
|
| Vol #:
|
| 68
|
|
|
| C 1421
|
| S. Greenlee
|
| Vol #:
|
| 68
|
|
|
| C 1422
|
| K. Goetze
|
| Vol #:
|
| 68
|
|
|
| C 1423
|
| V. Barro
|
| Vol #:
|
| 68
|
|
|
| C 1424
|
| K. Wyatt
|
| Vol #:
|
| 68
|
|
|
| C 1425
|
| A. Alessandra
|
| Vol #:
|
| 68
|
|
|
| C 1426
|
| B. Towles
|
| Vol #:
|
| 68
|
|
|
| C 1427
|
| C. Graney
|
| Vol #:
|
| 68
|
|
|
| C 1428
|
| C. Haia
|
| Vol #:
|
| 68
|
|
|
| C 1429
|
| J. Brown
|
| Vol #:
|
| 68
|
|
|
| C 1430
|
| J. Slominski
|
| Vol #:
|
| 68
|
|
| | | | | | | | |
|
|
| C 1431
|
| P. Newman
|
| Vol #:
|
| 68
|
|
|
| C 1432
|
| M. McCormick
|
| Vol #:
|
| 68
|
|
|
| C 1433
|
| M. Robichaud
|
| Vol #:
|
| 68
|
|
|
| C 1434
|
| C. Mozuch
|
| Vol #:
|
| 68
|
|
|
| C 1435
|
| R. Simmons
|
| Vol #:
|
| 68
|
|
|
| C 1436
|
| K. Barowitz
|
| Vol #:
|
| 68
|
|
|
| C 1437
|
| D. Rasnake
|
| Vol #:
|
| 68
|
|
|
| C 1438
|
| P. Patterson
|
| Vol #:
|
| 68
|
|
|
| C 1439
|
| B. Luther
|
| Vol #:
|
| 68
|
|
|
| C 1440
|
| N. Lubin
|
| Vol #:
|
| 68
|
|
|
| C 1441
|
| J. Bruning
|
| Vol #:
|
| 68
|
|
|
| C 1442
|
| SD Coggin
|
| Vol #:
|
| 68
|
|
|
| C 1443
|
| C. Zimmerman
|
| Vol #:
|
| 68
|
|
|
| C 1444
|
| A. White
|
| Vol #:
|
| 68
|
|
|
| C 1445
|
| D. Adney
|
| Vol #:
|
| 207
|
|
|
| C 1446
|
| L. Eagle
|
| Vol #:
|
| 207
|
|
|
| C 1447
|
| H. Walker
|
| Vol #:
|
| 207
|
|
|
| C 1448
|
| L. Kroll
|
| Vol #:
|
| 207
|
|
|
| C 1449
|
| C. Airing
|
| Vol #:
|
| 207
|
|
|
| C 1450
|
| P. Moss
|
| Vol #:
|
| 207
|
|
|
| C 1451
|
| D. Gagliarducci
|
| Vol #:
|
| 207
|
|
|
| C 1452
|
| S. Campbell
|
| Vol #:
|
| 207
|
|
|
| C 1453
|
| M. Valli
|
| Vol #:
|
| 207
|
|
|
| C 1454
|
| W. Herbert
|
| Vol #:
|
| 207
|
|
|
| C 1455
|
| K. Piazza
|
| Vol #:
|
| 207
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 18315
|
| L. Calmes
|
| Vol #:
|
| 198
|
|
|
| 2006P-0173
|
| Request approval of any abbreviated new drug application relying on Zosyn (piperacillin and tazobactam for injection) as its reference product be contingent upon the proposed product
|
|
|
|
|
|
|
| SUP 4
|
| Wyeth Laboratories
|
| Vol #:
|
| 1
|
|
|
| 2006P-0394
|
| Revise the labeling requirements for eggs sold in the United States
|
|
|
| C 99
|
| C. Maszk, T. Green & J. Green
|
| Vol #:
|
| 7
|
|
|
| 2007D-0117
|
| Guidance for Industry on Orally Disintegrating Tablets
| |
|
| C 3
|
| Schering-Plough
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| C 4
|
| Bristol-Myers Squibb Company
|
| Vol #:
|
| 1
|
|
|
| C 5
|
| Sanofi Aventis
|
| Vol #:
|
| 1
|
|
|
| C 6
|
| Novartis Pharmaceuticals Corp.
|
| Vol #:
|
| 1
|
|
|
| EC 6
|
| sanofi-aventis
|
| Vol #:
|
| 1
|
|
|
| EC 7
|
| Perrigo Company
|
| Vol #:
|
| 1
|
|
|
| 2007N-0121
|
| Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing
|
|
|
| EAPE 266
|
| Melfi, Catherine
|
| Vol #:
|
| 7
|
|
|
| EAPE 267
|
| Mehta, Rikin
|
| Vol #:
|
| 7
|
|
|
| EAPE 268
|
| Vincent, Andrea
|
| Vol #:
|
| 7
|
|
|
| EAPE 269
|
| De Santis, Marta
|
| Vol #:
|
| 7
|
|
|
| EAPE 270
|
| Robbins, Gabriel
|
| Vol #:
|
| 7
|
|
|
| 2007P-0224
|
| ANDA Suitability Petition for NDA 21-774 Ambien CR (Zolpidem tartrate)
|
|
|
| ACK 1
|
| FDA/DDM to Sanofi Aventis U.S. Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Sanofi Aventis U.S. Inc.
|
| Vol #:
|
| 1
|
|
|
| 2007P-0226
|
| to permit an ANDA suitability for Donepezil Hydrochloride Orally Dissolving Film Stripps, 5 mg and 10 mg
|
|
|
| ACK 1
|
| FDA / DDM to Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Lachman Consultant Services, Inc.
|
| Vol #:
|
| 1
|
|
|