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| Dockets Entered
On June 28, 2004
Table of Contents
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|
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|
|
|
|
| Docket
#
|
| Title
|
|
|
|
|
| 1976N-0052G
|
| OTC general comments
& combinations
|
|
|
| 1985V-0287
|
| Laser light show &
projector
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing
Health Claims & Nutrient Claims
|
|
|
| 1995P-0241
|
| Implied Nutrient Content
Claim "Healthy" & Health Claims
|
|
|
| 1997P-0056
|
| Caloric value not more
than two per gram for soluble fiber
|
|
|
| 1997V-0455
|
| Laser Light Show
|
|
|
| 1999E-5116
|
| Patent Extension: Xoponex,
levalbuterol hcl, #5,362,755
|
|
|
| 1999N-4282
|
| Biotechnology in the
Year 2000 and Beyond; Public Meetings
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry:
Opportunity for Hearing
|
|
|
| 2001P-0075
|
| Switch Status of Emergency
Contraceptives from Rx to OTC
|
|
|
| 2001P-0230
|
| Domestic Marketing &
Importation of Transgenic Fish
|
|
|
| 2001V-0084
|
| Laser light show
|
|
|
| 2002E-0149
|
| Genesis Neurostimulation
System, U.S. Patent No. 4,793,353
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior
Notice of Imported Food Shipments
|
|
|
| 2003D-0060
|
| Part11, Electronic records,
electronic signatures scope
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry
on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| 2003D-0290
|
| Compounding of Drugs
for Use in Animals Compliance Policy Guide
|
|
|
| 2003D-0571
|
| Guidance for Industry
on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
| 2003E-0150
|
| Patent extension ABILIFY
(aripiprazole) Patent No. 5,006,528
|
|
|
| 2003E-0153
|
| Patent Extension #5,420,319
for Eloxatin (oxaliplatin)
|
|
|
| 2003E-0246
|
| Patent Extension for
Deramaxx (deracoxib), 5,521,207,
|
|
|
| 2003E-0247
|
| Patent Extension for
Campath (Alemtuzumab), 5,545,403
|
|
|
| 2003E-0249
|
| Patent Extension for
Elitek (rasburicase) 5,382,518
|
|
|
| 2003E-0250
|
| Patent Extension for
Invanz (ertapenem sodium), 5,478,820
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel
(Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
|
|
|
| 2003E-0253
|
| Patent Extension for
Lexapro (escitalopram oxalate), 34,712
|
|
|
| 2003E-0257
|
| Patent Extension for
Neotame, 5,480,668
|
|
|
| 2003E-0261
|
| Patent Extension for
Strattera (atomoxetine hydrochloride), 5,658,590
|
|
|
| 2003E-0405
|
| Patent Term Restoraton
Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol,
zinc gluconate, Patent No. 4,937,234
|
|
|
| 2003N-0205
|
| Exocrine Pancreatic
Insufficiency Drug Products
|
|
|
| 2003N-0539
|
| Over-the-Counter Drug
Products; Safety and Efficacy Review
|
|
|
| 2003P-0387
|
| Request that the Commissioner
of Food and Drug take action described methodology for oral levothyroxine
sodium drug products
|
|
|
| 2003P-0544
|
| Modify existing food
additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| 2004N-0133
|
| Part 11, Electronic
Record; Electronic Signatures; Public Meeting
|
|
|
| 2004N-0221
|
| Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing
Practice Regulations; Public Meetings
|
|
| | | | | | | | |
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
|
|
| 2004P-0003
|
| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
|
|
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
| 2004P-0060
|
| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
|
|
|
| 2004P-0061
|
| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
|
|
|
| 2004P-0197
|
| ANADA for Pig Pump Oral Solution, NADA 130-464
|
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
| 2004P-0231
|
| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
| 2004V-0272
|
| Projector for a Laser Light Show
|
|
|
| 2004V-0273
|
| Laser Light Show
|
|
|
| 1976N-0052G
|
| OTC general comments & combinations
|
|
|
| LET
123
|
| Lil Drug Store Products, Inc.
|
| Vol #:
|
| 35
|
|
|
| 1985V-0287
|
| Laser light show & projector
|
|
|
| VRA
10
|
| HFZ-300 to Centrak Laser Design Group
|
| Vol #:
|
| 1
|
|
|
| 1994P-0390
|
| Adopt Amendments Governing Health Claims & Nutrient Claims
|
|
|
| C
61
|
| POM Wonderful, LLC
|
| Vol #:
|
| 5
|
|
|
| 1995P-0241
|
| Implied Nutrient Content Claim "Healthy" & Health Claims
|
|
|
| C
78
|
| POM Wonderful, LLC
|
| Vol #:
|
| 5
|
|
|
| 1997P-0056
|
| Caloric value not more than two per gram for soluble fiber
|
|
|
| C
1
|
| International Food Additives Council
|
| Vol #:
|
| 2
|
|
|
| 1997V-0455
|
| Laser Light Show
|
|
|
| VRA
4
|
| HFZ-300 to CourtYards of Mackinaw
|
| Vol #:
|
| 1
|
|
|
| 1999E-5116
|
| Patent Extension: Xoponex, levalbuterol hcl, #5,362,755
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 1999N-4282
|
| Biotechnology in the Year 2000 and Beyond; Public Meetings
|
|
|
| C 18226
|
| M. Lande
|
| Vol #:
|
| 516
|
|
|
| 2000N-1571
|
| Enrofloxacin for Poultry: Opportunity for Hearing
|
|
|
| EMC 791
|
| Charles Tazzia
|
| Vol #:
|
| 271
|
|
|
| EMC 792
|
| Jane Fronek
|
| Vol #:
|
| 271
|
|
| | | | | | | | |
|
|
| EMC 793
|
| Thomas Aldridge
|
| Vol #:
|
| 271
|
|
|
| EXB 161
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 415
|
|
|
| EXB 162
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 415
|
|
|
| EXB 163
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 415
|
|
|
| EXB 164
|
| Center for Veterinary Medicine
|
| Vol #:
|
| 415
|
|
|
| 2001P-0075
|
| Switch Status of Emergency Contraceptives from Rx to OTC
|
|
|
| EMC 7403
|
| B. Benton
|
| Vol #:
|
| 270
|
|
|
| EMC 7404
|
| V. Tarico
|
| Vol #:
|
| 279
|
|
|
| EMC 7405
|
| A. Ismach
|
| Vol #:
|
| 279
|
|
|
| EMC 7406
|
| D. Hart
|
| Vol #:
|
| 279
|
|
|
| EMC 7407
|
| N. Mcgowan
|
| Vol #:
|
| 279
|
|
|
| EMC 7408
|
| F. Hansen
|
| Vol #:
|
| 279
|
|
|
| EMC 7409
|
| P. Schneider
|
| Vol #:
|
| 279
|
|
|
| EMC 7410
|
| K. Rider
|
| Vol #:
|
| 279
|
|
|
| EMC 7411
|
| P. Goodwin M.D.
|
| Vol #:
|
| 279
|
|
|
| EMC 7412
|
| A. Brumback
|
| Vol #:
|
| 279
|
|
|
| EMC 7413
|
| S. Miller Pharm.D.
|
| Vol #:
|
| 279
|
|
|
| EMC 7414
|
| E. Bell
|
| Vol #:
|
| 279
|
|
|
| EMC 7415
|
| K. Tirimacco
|
| Vol #:
|
| 279
|
|
|
| EMC 7416
|
| K.. Kasameyer
|
| Vol #:
|
| 279
|
|
|
| EMC 7417
|
| C. Henry
|
| Vol #:
|
| 279
|
|
|
| EMC 7418
|
| R. & J. Lyle
|
| Vol #:
|
| 279
|
|
|
| EMC 7419
|
| J. Johnson
|
| Vol #:
|
| 279
|
|
|
| EMC 7420
|
| K. Daniels
|
| Vol #:
|
| 279
|
|
|
| EMC 7421
|
| S. McKibben
|
| Vol #:
|
| 279
|
|
|
| EMC 7422
|
| P. Jayne
|
| Vol #:
|
| 279
|
|
|
| EMC 7423
|
| C. J. Schroeder
|
| Vol #:
|
| 279
|
|
|
| EMC 7424
|
| C. Wurster
|
| Vol #:
|
| 279
|
|
|
| EMC 7425
|
| M. Patterson
|
| Vol #:
|
| 279
|
|
|
| EMC 7426
|
| M. Stacy
|
| Vol #:
|
| 279
|
|
|
| EMC 7427
|
| M. Cox
|
| Vol #:
|
| 279
|
|
|
| EMC 7428
|
| L. Raymond
|
| Vol #:
|
| 279
|
|
|
| EMC 7429
|
| P. Reynolds
|
| Vol #:
|
| 279
|
|
|
| EMC 7430
|
| D. Strasfogel
|
| Vol #:
|
| 279
|
|
|
| EMC 7431
|
| C. Lloyd
|
| Vol #:
|
| 279
|
|
|
| EMC 7432
|
| Siri Okamoto
|
| Vol #:
|
| 279
|
|
| | | | | | | | |
|
|
| EMC 7433
|
| S. Jackson
|
| Vol #:
|
| 279
|
|
|
| EMC 7434
|
| D. Therol-chaffin
|
| Vol #:
|
| 279
|
|
|
| EMC 7435
|
| L. Hershey
|
| Vol #:
|
| 279
|
|
|
| EMC 7436
|
| A. Musgierd
|
| Vol #:
|
| 279
|
|
|
| EMC 7437
|
| K. C. Tinghitella
|
| Vol #:
|
| 279
|
|
|
| EMC 7438
|
| W. Phinney
|
| Vol #:
|
| 279
|
|
|
| EMC 7439
|
| H. G. Kripal
|
| Vol #:
|
| 279
|
|
|
| EMC 7440
|
| P. Pitts
|
| Vol #:
|
| 279
|
|
|
| EMC 7441
|
| C. Hickey
|
| Vol #:
|
| 279
|
|
|
| EMC 7442
|
| C. Burleson
|
| Vol #:
|
| 179
|
|
|
| EMC 7443
|
| K. Drees
|
| Vol #:
|
| 279
|
|
|
| EMC 7444
|
| S. T.Kruger
|
| Vol #:
|
| 279
|
|
|
| EMC 7445
|
| K. Bohrer
|
| Vol #:
|
| 279
|
|
|
| EMC 7446
|
| L. Wickstrom
|
| Vol #:
|
| 279
|
|
|
| EMC 7447
|
| C. Saunders
|
| Vol #:
|
| 279
|
|
|
| EMC 7448
|
| D. Baum
|
| Vol #:
|
| 279
|
|
|
| EMC 7449
|
| L. Pfatteicher
|
| Vol #:
|
| 279
|
|
|
| EMC 7450
|
| E. Cook
|
| Vol #:
|
| 279
|
|
|
| EMC 7451
|
| L. Buntley
|
| Vol #:
|
| 279
|
|
|
| EMC 7452
|
| G. Heinrichs
|
| Vol #:
|
| 279
|
|
|
| EMC 7453
|
| H. Goodale
|
| Vol #:
|
| 279
|
|
|
| EMC 7454
|
| R. S. Morrison
|
| Vol #:
|
| 279
|
|
|
| EMC 7455
|
| L. Evans
|
| Vol #:
|
| 279
|
|
|
| EMC 7456
|
| R. K. Powers
|
| Vol #:
|
| 279
|
|
|
| EMC 7457
|
| S. Nett
|
| Vol #:
|
| 279
|
|
|
| EMC 7458
|
| J. R. beach
|
| Vol #:
|
| 279
|
|
|
| EMC 7459
|
| N. Cerkvenik
|
| Vol #:
|
| 279
|
|
|
| EMC 7460
|
| N. Cerkvenik
|
| Vol #:
|
| 279
|
|
|
| EMC 7461
|
| B. Johnson
|
| Vol #:
|
| 279
|
|
|
| EMC 7462
|
| M. Schrey
|
| Vol #:
|
| 279
|
|
|
| 2001P-0230
|
| Domestic Marketing & Importation of Transgenic Fish
|
|
|
| C 1358
|
| M. Lande
|
| Vol #:
|
| 259
|
|
|
| SUP
2
Attachment
|
| The Center for Food Safety (CFS)
|
| Vol #:
|
| 259
|
|
|
| 2001V-0084
|
| Laser light show
|
|
|
| VRA
2
|
| HFZ-300 to Frankenmuth river Place, LLC
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2002E-0149
|
| Genesis Neurostimulation System, U.S. Patent No. 4,793,353
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| C
349
|
| National Customs Brokers and Forwarders Assn of America, Inc. (NCBFAA)
|
| Vol #:
|
| 29
|
|
|
| 2003D-0060
|
| Part11, Electronic records, electronic signatures scope
|
|
|
| C
34
|
| Bulk Pharmaceuticals Task Force (BPTF)
|
| Vol #:
|
| 3
|
|
|
| 2003D-0206
|
| Draft Guidance for Industry on Exocrine Pancreatic Insufficiency Drug Products; Availability
|
|
|
| C
1
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| C
2
|
| Solvay Pharmaceuticals
|
| Vol #:
|
| 1
|
|
|
| 2003D-0290
|
| Compounding of Drugs for Use in Animals Compliance Policy Guide
|
|
|
| C
9
Part 2, Part
3,
Consumer
Letters
|
| International Academy of Compounding Pharmacists (IACP)
|
| Vol #:
|
| 2
|
|
|
| 2003D-0571
|
| Guidance for Industry on Drug Substance; Chemistry, Manufacturing, and Controls Information
|
|
|
| C
6
|
| Synthetic Chemical Manufacturer's Assn (SOCMA)
|
| Vol #:
|
| 1
|
|
|
| 2003E-0150
|
| Patent extension ABILIFY (aripiprazole) Patent No. 5,006,528
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0153
|
| Patent Extension #5,420,319 for Eloxatin (oxaliplatin)
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0246
|
| Patent Extension for Deramaxx (deracoxib), 5,521,207,
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0247
|
| Patent Extension for Campath (Alemtuzumab), 5,545,403
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0249
|
| Patent Extension for Elitek (rasburicase) 5,382,518
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0250
|
| Patent Extension for Invanz (ertapenem sodium), 5,478,820
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0251
|
| Patent 5,667,787, Daptacel (Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine)
|
|
|
| LET
3
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0253
|
| Patent Extension for Lexapro (escitalopram oxalate), 34,712
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2003E-0257
|
| Patent Extension for Neotame, 5,480,668
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0261
|
| Patent Extension for Strattera (atomoxetine hydrochloride), 5,658,590
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0405
|
| Patent Term Restoraton Application for Neutersol (zinc gluconate), U.S. Patent No. 5,070,080
|
|
|
| LET
4
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003E-0452
|
| Patent Extension, Neutersol, zinc gluconate, Patent No. 4,937,234
|
|
|
| LET
5
|
| HFD-005 to US Patent & Trademark Office
|
| Vol #:
|
| 1
|
|
|
| 2003N-0205
|
| Exocrine Pancreatic Insufficiency Drug Products
|
|
|
| C
1
|
| Scientific Protein Laboratories, LLC
|
| Vol #:
|
| 1
|
|
|
| C
2
|
| Digestive Care, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003N-0539
|
| Over-the-Counter Drug Products; Safety and Efficacy Review
|
|
|
| C
2
|
| C.B. Fleet Company, Inc. (C.B. Fleet)
|
| Vol #:
|
| 1
|
|
|
| C
3
|
| Personal Products Company
|
| Vol #:
|
| 1
|
|
|
| C
4
Table of Contents,
Tab 1, 2,
3-8
|
| INGfertility
|
| Vol #:
|
| 3
|
|
|
| C
5
Attachment,
Appendices, Tabulations
|
| Johnson & Johnson
|
| Vol #:
|
| 4
|
|
|
| C
6
Exhibits
|
| B.F. Ascher & Company, Inc.
|
| Vol #:
|
| 5
|
|
|
| 2003P-0387
|
| Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
|
|
|
| MM 1
|
| FDA & Abbott Laboratories met January 13, 2004
|
| Vol #:
|
| 5
|
|
|
| 2003P-0544
|
| Modify existing food additive regulation with respect to the irradiation of ground beef byproducts
|
|
|
| C 36
|
| M. Lande
|
| Vol #:
|
| 2
|
|
|
| 2004N-0133
|
| Part 11, Electronic Record; Electronic Signatures; Public Meeting
|
|
|
| C
10
|
| The Dow Chemical Company (DOW)
|
| Vol #:
|
| 4
|
|
|
| 2004N-0221
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| Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Section 107(f) b
|
|
|
| C
10
|
| ASKO Corporation
|
| Vol #:
|
| 1
|
|
|
| C 11
|
| J. Sanders
|
| Vol #:
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| 1
|
|
|
| C 12
|
| W. Cater
|
| Vol #:
|
| 1
|
|
|
| C
13
|
| En Vision America, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004N-0230
|
| Food; Current Good Manufacturing Practice Regulations; Public Meetings
|
|
|
| APE 1
|
| Morton Salt
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2004N-0254
|
| Possible Barriers to the Availability of Medical Devices Intended to Treat or Diagnose Diseases and Conditions that Affect Children
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004P-0003
|
| Petition to reconsider the Food and Drug Administration's decision on the Med Watch complaint
|
|
|
| LET 5
|
| Billy G. Pierson
|
| Vol #:
|
| 1
|
|
|
| LET 6
|
| Billy G. Pierson
|
| Vol #:
|
| 1
|
|
|
| LET 7
|
| Billy G. Pierson
|
| Vol #:
|
| 1
|
|
|
| 2004P-0059
|
| Health Claim Petition: Glucosamine and Chondroitin Sulfate and Osteoarthritis
|
|
|
| SUP
7
Attachment
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 13
|
|
|
| 2004P-0060
|
| Health Claim Petition: Glucosamine Sulfate and Osteoarthritis
|
|
|
| SUP
2
Attachment
|
| Weider Nutrition International, Inc.
|
| Vol #:
|
| 3
|
|
|
| 2004P-0061
|
| Take actions to establish guidance and clarify requirements for abbreviated new drug applications with regard to levothyroxine sodium products
|
|
|
| MM 1
|
| FDA & Jerome Stevens Pharmaceuticals Inc met April 14, 2004
|
| Vol #:
|
| 1
|
|
|
| PDN
1
|
| HF-22 to Alston & Bird, LLP
|
| Vol #:
|
| 1
|
|
|
| 2004P-0197
|
| ANADA for Pig Pump Oral Solution, NADA 130-464
|
|
|
| PAV
1
|
| HFV-100 to First Priority, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2004P-0202
|
| Notify State & Federal regulators of GRAS requirements of milk protein Concentrate
|
|
|
| C 7
|
| L. Smith
|
| Vol #:
|
| 1
|
|
|
| 2004P-0231
|
| Deny approval of NDA 21-426 for Ominitrop 5.8 mg somatropin [ rDNA origin ] for injection, lyophilized powder and diluent with preservative
|
|
|
| C
1
|
| Engel & Novitt, LLP
|
| Vol #:
|
| 2
|
|
|
| 2004S-0270
|
| Notice Announcing Publication of the Report to Congress Entitled Plan for the Transfer of Responsibility for Medicare Appeals and Soliciting Comments
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| 2004V-0272
|
| Projector for a Laser Light Show
|
|
|
| ACK 1
|
| HFA-305 toFan Yang
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| Fan Yang
|
| Vol #:
|
| 1
|
|
|
| 2004V-0273
|
| Laser Light Show
|
|
|
| ACK 1
|
| HFA-305 to Vybe Entertainment
|
| Vol #:
|
| 1
|
|
|
| VAR
1
|
| VybeEntertainment
|
| Vol #:
|
| 1
|
|
|