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Dockets Management

Dockets Entered On June 27, 2007
Docket # Title
1976N-0052N OTC Nasal Decongestants
1994P-0199 ANDA Suitability for Lorazepam Oral Solution
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
2004P-0262 Withdraw approval of ANDA suitability petition
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2007E-0256 Patent Extension Application for TEKTURNA (Aliskiren hemifumarate), U.S. Patent No. 5,559,111
2007E-0257 Patent Extension Application for TYKERB Tablets (lapatinib), U.S. Patent No. 6,713,485
2007N-0051 Safety of Fresh Produce; Public Hearings
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
2007V-0258 Laser Camera System
1976N-0052N OTC Nasal Decongestants
SUP 13 Consumer Healthcare Products Association (CHPA) Vol #: 109
1994P-0199 ANDA Suitability for Lorazepam Oral Solution
LET 1 Roxane Laboratories Vol #: 1
1996N-0417 CGMP in Mfg. Packing or Holding Dietary Supplements
BKG 2 Background Information Vol #: 44
NFR 1 FDA Vol #: 50
2004P-0262 Withdraw approval of ANDA suitability petition
LET 2 Rozane Laboratories Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18322 K. Aubuchan Vol #: 198
2007E-0256 Patent Extension Application for TEKTURNA (Aliskiren hemifumarate), U.S. Patent No. 5,559,111
APP 1 Novartis Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 1
2007E-0257 Patent Extension Application for TYKERB Tablets (lapatinib), U.S. Patent No. 6,713,485
APP 1 SmithKline Beecham Corporation Vol #: 1
LET 1 U.S. Patent and Trademark Office to FDA/CDER Vol #: 2
2007N-0051 Safety of Fresh Produce; Public Hearings
EC 13 Consumer Federation of America Vol #: 2
EC 14 Association of Food and Drug Officials Vol #: 2
EC 15 Canadian Food Inspection Agency Vol #: 2
EC 16 Ohio Farm Bureau Federation, Inc. Vol #: 2
EC 17 GMA/FPA Vol #: 2
EC 18 The Ohio Roundtable on Produce Safety Vol #: 2
EC 19 U.S. Apple Association Vol #: 2
EC 20 Dr. Melissa Mundo Vol #: 2
EC 21 National GAPs Program, Cornell University Vol #: 2
2007P-0085 Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
C 157 G. Dinstuhl Vol #: 6
C 158 D. Hill Vol #: 6
C 159 J. Berry Vol #: 6
C 160 K. Lewis Vol #: 6
EC 561 Ms. Anne Kogan Vol #: 3
EC 562 submitting comment as an individual Vol #: 3
EC 563 Mr. David paul Vol #: 3
EC 564 Mrs. Laurie Gresser Vol #: 3
EC 565 na Vol #: 3
EC 566 Ms. susan cottee Vol #: 3
EC 567 Mrs. Ruthie Price Vol #: 3
EC 568 The Chocolate Gallery Vol #: 3
EC 569 Don't Mess With Our Chocolate Vol #: 3
EC 570 Ms. Kelly Wright Vol #: 3
EC 571 Don't Mess with Our Chocolate Vol #: 3
EC 572 Ms. Pamela Hlad Vol #: 3
EC 573 Ms. Sarah Blackstock Vol #: 3
EC 574 Miss. fabiola gallipoli Vol #: 3
EC 575 DONT MESS WITH OUR CHOCOLATE Vol #: 3
EC 576 Ms. Patricia Sulewski Vol #: 3
EC 577 Ms. Rachel Gonzalez Vol #: 3
EC 578 Ms. MaryAnn Hay Vol #: 3
EC 579 Ms. Susan Parker Vol #: 3
EC 580 Ms. Debbie DiPatri Vol #: 3
EC 581 Ms. linda nelson Vol #: 3
EC 582 Ms. Donna Kelly Vol #: 3
EC 583 Don't Mess With Our Chocolate Vol #: 3
EC 584 Mr. Jason Schepers Vol #: 3
EC 585 Mr. Robert Davidson Vol #: 3
EC 586 Mr. Connor Choka Vol #: 3
EC 587 Mrs. Brenda Turner Vol #: 3
EC 588 Ms. Julie Barrett Cataldo Vol #: 3
EC 589 Ms. Lilas Harley Vol #: 3
EC 590 THE NIBBLE Vol #: 3
EC 591 Mrs. Kate Gurney Vol #: 3
EC 592 Mrs. Joyce Greer Vol #: 3
EC 593 Mrs. SA Jeffrey Vol #: 3
EC 594 Mr. John Lewis Vol #: 3
EC 595 Ms. Brooke Boston Vol #: 3
EC 596 Ms. J Zemsky Vol #: 3
EC 597 Don't Mess With Our Chocolate Vol #: 3
EC 598 Mrs. Lauren Snell Vol #: 3
EC 599 Ms. Pamela MacKenzie Vol #: 3
EC 600 Ms. Cindy Morgan Vol #: 3
EC 601 Ms. Melissa Newman Vol #: 3
EC 602 Ms. Melissa Getreu Vol #: 3
EC 603 Don't Mess With Our Chocolate Vol #: 3
EC 604 Ms. Kim Graham Vol #: 3
EC 605 Mr. matthew hepburn Vol #: 3
EC 606 Mr. Jesus MacLean Vol #: 3
EC 607 Mr. Trevor Graham Vol #: 3
EC 608 Amano Artisan Chocolate Vol #: 3
EC 609 Miss. M Fredriksson Vol #: 3
EC 610 Mr. Chris Toomey Vol #: 3
EC 611 Don't Mess With Our Chocolate Vol #: 11
EC 612 Don't Mess with our Chocolate Vol #: 11
EC 613 Ms. Tabitha Steager Vol #: 11
EC 614 Mrs. Judith Harrison Vol #: 11
EC 615 Don't Mess With Our Chocolate Vol #: 11
EC 616 Ms. Rebeckah Johnson Vol #: 11
EC 617 Don't Mess With Our Chocolate Vol #: 11
EC 618 Ms. Brenda Tait Vol #: 11
EC 619 Don't Mess with Our Chocolate Vol #: 11
EC 620 Don't Mess With Our Chocolate Vol #: 11
EC 621 Miss. Sally Johnson Vol #: 11
EC 622 don't mess with our chocolate Vol #: 11
EC 623 Mrs. Rachel Hohensee Vol #: 11
EC 624 Miss. Genna Feinberg Vol #: 11
EC 625 Mrs. Judy Lorensen Vol #: 11
EC 626 Miss. Mira Ederer Vol #: 11
EC 627 Mr. Joel Knight Vol #: 11
EC 628 Ms. Jill Coombs Vol #: 11
EC 629 Ms. Atara Morgan Vol #: 11
EC 630 Mrs. Robin Williams Vol #: 11
EC 631 Bogolea Marketing Vol #: 11
2007V-0258 Laser Camera System
ACK 1 FDA / DDM to Neptec Design Group Vol #: 1
VAR 1 Neptec Design Group Vol #: 1

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