Food and Drug Administration,  Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail]  

DOCKETS ENTERED on May 25, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
97S-0162 30-Day Structure Function Claim Notification Letters Dietary *
98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA *
99P-2850 Paricalcitol to Priority List of Approved Drugs *
99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease *
99P-4613 Revoke the Regulation That Approved Posilac *
00M-1212 Ray TFC & Ray TFC Unite Threaded Fusion Case w/Instrumentati *
00M-1298 Cutting Balloon, P950020 *
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids *
00N-1256 Over-the-Counter Drug Products;Public Hearing *
00P-1276 Health Claim: Plant stanol esters and heart disease *
00P-1304 Variance from application of the performance standard *
00P-1308 Methimazole tablets USP,15mg/20mg are suitable for ANDA *
97S-0162 30-Day Structure Function Claim Notification Letters Dietary

LET 4512 Standard Process Vol#: 34

LET 4513 Standard Process Vol#: 34

LET 4514 Standard Process Vol#: 34

LET 4515 Standard Process Vol#: 34

LET 4516 Standard Process Vol#: 34

LET 4517 Standard Process Vol#: 34

LET 4518 Standard Process Vol#: 34

LET 4519 Standard Process Vol#: 34

LET 4520 Standard Process Vol#: 34

LET 4521 Standard Process Vol#: 34

LET 4522 Standard Process Vol#: 34

LET 4523 Standard Process Vol#: 34

LET 4524 Standard Process Vol#: 34

LET 4525 Standard Process Vol#: 34

LET 4526 Standard Process Vol#: 34

LET 4527 Standard Process Vol#: 34

LET 4528 Super Blue Green Cell Tech Vol#: 34

LET 4529 Standard Process Vol#: 34

LET 4530 En Garde Health Products, Inc. Vol#: 34

LET 4531 En Garde Health Products, Inc. Vol#: 34

LET 4532 En Garde Health Products, Inc. Vol#: 34

LET 4533 En Garde Health Products, Inc. Vol#: 34

LET 4534 En Garde Health Products, Inc. Vol#: 34

LET 4535 En Garde Health Products, Inc. Vol#: 34

LET 4536 En Garde Health Products, Inc. Vol#: 34

LET 4537 En Garde Health Products, Inc. Vol#: 34

LET 4538 En Garde Health Products, Inc. Vol#: 34

LET 4539 En Garde Health Products, Inc. Vol#: 34

LET 4540 En Garde Health Products, Inc. Vol#: 34

LET 4541 Natrol, Inc. Vol#: 34

LET 4542 Natrol, Inc. Vol#: 34

LET 4543 Natrol, Inc. Vol#: 34

LET 4544 Knox Company Vol#: 34

LET 4545 Natrol, Inc. Vol#: 34

LET 4546 Standard Process Vol#: 34

LET 4547 Standard Process Vol#: 34

LET 4548 Columbia Laboratories, Inc. Vol#: 34

LET 4549 Standard Process Vol#: 34

LET 4550 Standard Process Vol#: 34

LET 4551 Standard Process Vol#: 34

LET 4552 Standard Process Vol#: 34

LET 4553 Standard Process Vol#: 34

LET 4554 Standard Process Vol#: 34

LET 4555 Standard Process Vol#: 34

LET 4556 Standard Process Vol#: 34

LET 4557 AMBI Inc. Vol#: 34

LET 4558 Provenance Vol#: 34

LET 4559 Rite Aid Corporation Vol#: 34

LET 4560 Rainbow Light Nutritional Systems, Inc. Vol#: 34

LET 4561 USANA, Inc. Vol#: 34

LET 4562 Nature's Sunshine Products, Inc. Vol#: 34

LET 4563 Standard Process Vol#: 34

LET 4564 Standard Process Vol#: 34

LET 4565 Standard Process Vol#: 34

LET 4566 Standard Process Vol#: 34

LET 4567 Standard Process Vol#: 34

LET 4568 Standard Process Vol#: 34

LET 4569 Standard Process Vol#: 34

LET 4570 Standard Process Vol#: 34

LET 4571 Standard Process Vol#: 34

LET 4572 Standard Process Vol#: 34

LET 4573 Standard Process Vol#: 34

LET 4574 Standard Process Vol#: 34

LET 4575 Standard Process Vol#: 34

LET 4576 Standard Process Vol#: 34

LET 4577 Standard Process Vol#: 34

LET 4578 Standard Process Vol#: 34

LET 4579 Standard Process Vol#: 34

LET 4580 Standard Process Vol#: 34

LET 4581 Standard Process Vol#: 34

LET 4582 Standard Process Vol#: 34

LET 4583 Standard Process Vol#: 34

LET 4584 Standard Process Vol#: 34

LET 4585 Standard Process Vol#: 34

LET 4586 Standard Process Vol#: 34

LET 4587 Standard Process Vol#: 34

98N-0056 Sec 111(b)Pediatric Studies of list of Approved Drugs FDAMA

LET 12 HFD-1 to Abbott Labs. Vol#: 3

99P-2850 Paricalcitol to Priority List of Approved Drugs

PAV 1 HFD-1 to Abbott Labs. Vol#: 1

99P-3029 Health Claim: Folic Acid, Vitamin B6 etc & Vascular Disease

THE LINKED COMMENTS BELOW DUPLICATE THOS FOR 99P-3030, ALSO BELOW.

C 196 Dorothy D Vanderbilt Vol#: 8

C 197 Helen Cullum Vol#: 8

99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia

C 195 Dorothy D Vanderbuilt Vol#: 5

C 196 Helen Cullum Vol#: 5

99P-4613 Revoke the Regulation That Approved Posilac

C 184 April Hosty Vol#: 26

C 185 Mrs. Ann Mallow Vol#: 26

C 186 Brenda Shoss Vol#: 26

00M-1212 Ray TFC & Ray TFC Unite Threaded Fusion Case w/Instrumentati

AAV 1 United Surgical Vol#: 1

00M-1298 Cutting Balloon, P950020

AAV 1 Interventional Technologies Inc Vol#: 1

00N-1200 Dietary Supplements Containing Ephedrine Alkaloids

C 1 Durk Pearson & Sandy Shaw Vol#: 59

00N-1256 Over-the-Counter Drug Products;Public Hearing

APE 20 Q2 Marketing Research, Inc. Vol#: 2

APE 21 American Life League, Inc. Vol#: 2

APE 22 Hill Top Research Vol#: 2

APE 23 The Boots Company plc Vol#: 2

APE 24 Consumer Healthcare Products Assoc Vol#: 2

CH 14 Robert Copeland Vol#: 1

CH 15 Marsha A. Ashton Vol#: 1

CH 16 Frances B. Kelly Vol#: 1

CH 17 Olga Fairfax, PhD Vol#: 1

CH 18 Betty Townsend Vol#: 1

CH 19 Wade H. Poole, III Vol#: 1

CH 20 Interam College of Physicians & Surgeons Vol#: 1

CH 21 Raymond F. Mulhern Vol#: 1

CH 22 Victoria T. De Lacy Vol#: 1

CH 23 Susan C. Schildwachter Vol#: 1

CH 24 Chris Kahlenborn, MD Vol#: 1

00P-1276 Health Claim: Plant stanol esters and heart disease

CP 1 McNeil Consumer Healthcare Vol#: 1

00P-1304 Variance from application of the performance standard

ACK 1 HFA-305 Vol#: 1

00P-1308 Methimazole tablets USP,15mg/20mg are suitable for ANDA

ACK 1 HFA-305 Vol#: 1