 | 1971 - 748 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and (ii) If the article is subject to section 505,... | |
 | 1997 - 200 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and (2) If the article is subject to section 505,... | |
 | 1994 - 196 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...administer the drug can use the drug safely and for the pur§201.100 poses for which it is intended, including all purposes for which it is advertised or represented;... | |
 | 1990 - 198 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...administer the drug can use the drug safely and for trie purposes for which it is intended, including all purposes for which it is advertised or represented;... | |
 | 1963 - 1124 pagini
...for its use, including indications, effects, dosages, routes, methods, and frequency §1.106 §1.106 and duration of administration, and any relevant hazards,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and <ii) If the article is subject to section 505,... | |
 | 1981 - 1252 pagini
...also be insufficient if: (1) The specimen labeling proposed fails to bear adequate information for use, including indications, effects, dosages, routes,...licensed by law to administer the drug can use the drug for the purposes for which it is intended, including all purposes for which it is to be advertised,... | |
 | United States. Congress. Senate. Committee on the Judiciary - 1961 - 754 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented ; and, if the article is subject to section 505,... | |
 | 1967 - 454 pagini
...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented. . . ." The package insert originates as a part... | |
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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,... 
