The Code of Federal Regulations of the United States of AmericaU.S. Government Printing Office, 1993 The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. |
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1.–5. rezultāts no 41.
5. lappuse
... testing laboratories , contract packers or labelers , and custom grinders , and regards extramu- ral facilities as an extension of the manufacturer's own facility . ( c ) The Food and Drug Administra- tion reserves the right to disclose ...
... testing laboratories , contract packers or labelers , and custom grinders , and regards extramu- ral facilities as an extension of the manufacturer's own facility . ( c ) The Food and Drug Administra- tion reserves the right to disclose ...
10. lappuse
... testing of samples taken during processing , as follows : ( 1 ) By individuals , a majority of whom are employees of the person and , throughout the performance of the operation , are subject to the per- son's direction 10 § 201.1 21 ...
... testing of samples taken during processing , as follows : ( 1 ) By individuals , a majority of whom are employees of the person and , throughout the performance of the operation , are subject to the per- son's direction 10 § 201.1 21 ...
20. lappuse
... tests and that have not been shown by adequate and well - controlled clinical studies to be pertinent to clinical use may be included under this section of the labeling only under the following circumstances : ( i ) In vitro data for ...
... tests and that have not been shown by adequate and well - controlled clinical studies to be pertinent to clinical use may be included under this section of the labeling only under the following circumstances : ( i ) In vitro data for ...
21. lappuse
... tests needed for selection or monitoring of the pa- tients who need the drug , e.g. , microbe susceptibility tests . Information on the approximate kind , degree , and du- ration of improvement to be anticipat- ed shall be stated if ...
... tests needed for selection or monitoring of the pa- tients who need the drug , e.g. , microbe susceptibility tests . Information on the approximate kind , degree , and du- ration of improvement to be anticipat- ed shall be stated if ...
22. lappuse
... tests : This subsection of the labeling shall identify any labo- ratory tests that may be helpful in fol- lowing the patient's response or in identifying possible adverse reactions . If appropriate , information shall be provided on ...
... tests : This subsection of the labeling shall identify any labo- ratory tests that may be helpful in fol- lowing the patient's response or in identifying possible adverse reactions . If appropriate , information shall be provided on ...
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active ingredient adequate advertisement amended appropriate approved batch bear beling cation chapter chlorcyclizine clinical closures cluding Code contraindications control number Cosmetic Act cyclizine detoxification distribution distributor dosage form dose Drug Administration drug application Drug Enforcement Administration drug establishment drug listing drug prod drug product containers equipment established name evaluation exemption expiration date facture Federal Food Federal Register Food and Drug gram hexachlorophene intended licensed maintenance treatment manu manufac manufacturing meclizine medicated article(s medicated feed ment Methadone misbranded name or designation narcotic narcotic drugs National Office operations oral over-the-counter over-the-counter drug packaging and labeling packing paragraph patient patient's record pernicious anemia person potassium permanganate pregnancy Pregnancy category preparations prescription drugs principal display panel processing program physician proprietary name quired regulations safety sample shipment side effects specific storage submitted Subpart tained testing tients tion treatment program ture Type A medicated ucts
Populāri fragmenti
45. lappuse - Indications Based on a review of this drug by the National Academy of Sciences — National Research Council and/or other information, FDA has classified the indications as follows: Effective: For the management of the manifestations of psychotic disorders.
23. lappuse - There are. however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed...
24. lappuse - ProHance* should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
25. lappuse - Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Lortab 7.5/500 tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
38. lappuse - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
x. lappuse - All prices include regular domestic postage and handling and are subject to change. (Company or personal name) (Additional address/attention line) (Street address) 3.
53. lappuse - The same information concerning the ingredients of the drug as appears on the label and labeling on or within the package from which the drug is to be dispensed...
42. lappuse - REGULATIONS MAKING EXEMPTIONS SEC. 405. The Secretary shall promulgate regulations exempting from any labeling requirement of this Act (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this Act upon...
25. lappuse - Nursing Mothers: It is not known whether this drug is excreted in human milk Because many drugs are excreted in human milk, caution should be exercised when sucralfate is administered to a nursing woman...
16. lappuse - USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen In patients who also have aspirin hypersensitivity.