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FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
Food and Drug Administration, HHS
of benign prostatic hypertrophy cannot be generally recognized as safe and effective. (b) Any OTC drug product that is labeled, represented, or promoted to relieve the symptoms of benign prostatic hypertrophy is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration Rockville, MD 20857
TRANSMITTED BY FACSIMILE Joy E. Ferrell Senior Director, Regulatory Affairs GlaxoSmithKline PO Box 13398 Five Moore Drive Research Triangle Park, NC 27709 RE: NDA 20-121 Flonase (fluticasone propionate) Nasal Spray, 50 mcg MACMIS ID#: 115 ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER_FOR DRUG EVALUATION AND RESEARCH 7520 Standish Place Rockville, Maryland 20855 USA Date: March 27, 2000 Ref. No. 00-HFD-310I - 018
Mr. John W. P.O. Box 17205 Athens, -- 10024 - Greece Dear John W:
This is to advise you that the Food and Drug Administr ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service __________________________________________________________________________________ _ Food and Drug Administration 7520 Standish Place - Room 254 Rockville, MD 20855 August 24, 2000 Ms. Dolores Brash PO Box 2361 Sardis Station Main Chilliwack, BC V2R 1A7 Canada Dear Ms. Brash: This is to ad ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service __________________________________________________________________________________ _ Food and Drug Administration 7520 Standish Place - Room 254 Rockville, MD 20855 October 26, 2000 Ref. No. 01-HFD-310I-043 Ms. Kathi Quan Web Dreams Design 3019 Valasstrada Ct Carmichael CA 95608 Dear Ms. Q ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
HUMAN DRUG CGMP NOTES
(Volume 1, Number 2) May, 1993 (A Newsletter on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals) Issued By: The Division of Manufacturing and Product Quality, HFD-320 Office of Compliance Center for Drug Evaluation and Research
Editor: Paul J. Motise, HFD-323 Circulation Manager: Gayle Dolecek, HFD-32 ... more>>
FDADocs 5/12/2008 | 0 (0) | 20 | 0 | 0 | English
Contains Nonbinding Recommendations Draft Guidance on Ziprasidone Hydrochloride This draft guidance, once finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approac ... more>>
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