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DOCKETS ENTERED on 2/14/03

Docket Number - Title

77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products *
00N-0018 Reclassification of the knee joint Patellofemorotibal Metal *
00P-1227 Amend Statements Made for Dietary Supplements *
01P-0440 ANDA Suitability Petition for Ganciclovir Sodium Injection *
02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives *
02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20 *
02P-0233 Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA *
02P-0245 ANDA for Fludarabine Phosphate Injection, 25 mg/ML *
02P-0285 Combination oxycodone hydrochloride/acetaminophen tablet *
02P-0367 Doxycycline hyclate capsules 20mg,Periostat capsules,20mg *
02P-0374 Angiotensin Converting Enzyme inhibitors a Black Box warning *
02P-0462 Use of Implied Nutrient Content Claim - "Carbolite" *
77N-0094 OTC Internal Analgesic, Antipyretic & Antirheumatic Products

ACK 3 HFA-305 to Bayer Health Care Vol#: 244

CP 16 Bayer Healthcare, LLC Vol#: 244

99V-0893 Coherent Star II PL White Light Laser,Divine Lightwave Tech

VRA 2 HFZ-480 to Cranbrook Institute of Scienc Vol#: 1

00N-0018 Reclassification of the knee joint Patellofemorotibal Metal

PAV 1 HFZ-400 to Orthopedic Surgical Manufactu Vol#: 1

00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods

EMC 5553 Racheal Fabiani Vol#: 785

EMC 5554 Katrin Saucier Vol#: 785

EMC 5555 Cecile Harrison Vol#: 785

EMC 5556 Lynette Liechty Vol#: 785

EMC 5557 Gordon Gacek Vol#: 785

00P-1227 Amend Statements Made for Dietary Supplements

PDN 1 HF-22 to CSPI Vol#: 1

01P-0440 ANDA Suitability Petition for Ganciclovir Sodium Injection

PAV 1 HFD-601 to Ben Venue Laboratories, Inc. Vol#: 1

01V-0137 Laser light show & projectors: Q-Beam Series

VRA 1 HFZ-480 to DJ Supply Vol#: 1

02P-0013 Rescind GRAS Status for Aluminum-containing Food Additives

LET 2 HFS-265 to Colin G. Meyer, D.V.M., Ph.D. Vol#: 1

02P-0078 ANDA for Baclofen Orally Disintegrating Tablets, 10 mg & 20

PAV 1 HFD-601 to Kleinfeld, Kaplan & Becker Vol#: 1

02P-0233 Hydrocodone Bitartrate/Acetaminophen orally 5mg/500mg ANDA

PAV 1 HFD-601 to Kleinfeld, Kaplan and Backer Vol#: 1

02P-0245 ANDA for Fludarabine Phosphate Injection, 25 mg/ML

PAV 1 HFD-601 to Gensia Sicor Pharmaceuticals Vol#: 1

02P-0285 Combination oxycodone hydrochloride/acetaminophen tablet

PDN 1 HFD-601 to King & Spalding Vol#: 1

02P-0367 Doxycycline hyclate capsules 20mg,Periostat capsules,20mg

LET 1 HFD-1 to West-Ward Pharmaceutical Corp. Vol#: 1

02P-0374 Angiotensin Converting Enzyme inhibitors a Black Box warning

LET 1 HFD-1 to Boston Medicine Center Vol#: 1

02P-0462 Use of Implied Nutrient Content Claim - "Carbolite"

ACK 2 HFA-305 Vol#: 2

PRC 1 Carbolite Foods, Inc. Vol#: 2

02V-0517 Laser Light Show

VRA 1 HFZ-480 to Psyteknology Vol#: 1