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Grāmatas Grāmatas
" ... drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the... "
The Code of Federal Regulations of the United States of America - 125. lappuse
1992
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United States Code, 6. sējums

United States - 1977 - 1276 lapas
...used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity,...reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (C) that on the basis of new information before him,...
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United States Code, 2. sējums

United States - 1964 - 1098 lapas
...used in. or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity,...reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) that on the basis of new information before him,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1998 - 1120 lapas
...and controls used for, the manufacture, processing, and packing of the drug are Inadequate to ensure and preserve Its identity, strength, quality, and...together with the evidence available when the application or abbreviated application was approved, the labeling of the drug, based on a fair evaluation of all...
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Code of Federal Regulations: Containing a Codification of Documents of ...

2000 - 440 lapas
...and controls used for, the manufacture, processing, and packing of the drug are inadequate to ensure and preserve its identity, strength, quality, and...together with the evidence available when the application or abbreviated application was approved, the labeling of the drug, based on a fair evaluation of all...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 372 lapas
...and controls used for, the manufacture, processing, and packing of the drug are inadequate to ensure and preserve its identity, strength, quality, and...together with the evidence available when the application or abbreviated application was approved, the labeling of the drug, based on a fair evaluation of all...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1996 - 1130 lapas
...and controls used for, the manufacture, processing, and packing of the drug are inadequate to ensure and preserve its identity, strength, quality, and...agency. (3) That on the basis of new information before PDA, evaluated together with the evidence available when the application or abbreviated application...
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The Code of Federal Regulations of the United States of America

2006 - 616 lapas
...facilities and controls used for, the manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve its identity,...reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him,...
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The Code of Federal Regulations of the United States of America

1986 - 792 lapas
...facilities and controls used for the manufacture, processing, and packing of such drug or animal feed are inadequate to assure and preserve its identity,...reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him,...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1965 - 1520 lapas
...evaluated together with the evidence available when the application was approved, the methods used to, or the facilities and controls used for, the manufacture,...preserve its identity, strength, quality, and purity; or (3) That on the basis of new Information before the Food and Drug Administration, evaluated together...
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The Code of Federal Regulations of the United States of America

1988 - 772 lapas
...processing, and packing of such drug or animal feed are inadequate to 21 CFR Ch. I (4-1-88 Edition} assure and preserve its identity, strength, quality,...reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) That on the basis of new information before him,...
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