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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,... "
The Code of Federal Regulations of the United States of America - 19. lappuse
1967
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Code of Federal Regulations: Containing a Codification of Documents of ...

1971 - 748 lapas
...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,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1997 - 200 lapas
...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,...
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The Code of Federal Regulations of the United States of America

1994 - 196 lapas
...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;...
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Code of Federal Regulations: 1985-1999

1990 - 198 lapas
...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;...
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The Code of Federal Regulations of the United States of America

1963 - 1124 lapas
...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,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 1252 lapas
...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,...
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Drug Industry Antitrust Act: Hearings Before the Subcommittee on ..., 5-6. daļas

United States. Congress. Senate. Committee on the Judiciary - 1961 - 754 lapas
...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,...
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Competitive Problems in the Drug Industry, 4. sējums;6. sējums

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - 1968 - 424 lapas
...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 (the new drug,...
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FDA Papers, 1. sējums

1967 - 454 lapas
...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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Competitive Problems in the Drug Industry: Hearings, Ninetieth Congress ...

United States. Congress. Senate. Select Committee on Small Business. Committee on Monopoly - 1975 - 484 lapas
...condition requires that any labeling of a prescription drug shall contain adequate information for use including indications, effects, dosages, routes,...administer the drug can use the drug safely and for the purpose for which it is intended and, if the drug is subject to 21 USC 355, the labeling providing...
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