 | 1999 - 220 lapas
...manufacturer's original package is designed and intended to be dispensed to patients without repackaging. (c)(l) Labeling on or within the package from which...contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for... | |
 | 1963 - 1124 lapas
...required by subdivision (vi) of this subparagraph may be on the crimp of the dispensing tube. (3)(i) Labeling on or within the package from which the drug...indications, effects, dosages, routes, methods, and frequency §1.106 §1.106 and duration of administration, and any relevant hazards, contraindications, side effects,... | |
 | 1979 - 1056 lapas
...also be insufficient if: (1) The specimen labeling proposed fails to bear adequate information for use, including indications, effects, dosages, routes,...contraindications, side effects, and precautions, under which practitioners licensed by law to administer the drug can use the drug for the purposes for which it... | |
 | 1964 - 1242 lapas
...purports to furnish information for use of the drug will contain substantially the same information for use, including indications, effects, dosages, routes,...contraindications, side effects, and precautions, which is contained in the labeling that is part of the application, in accordance with § 1.106 (b)... | |
 | 2000 - 736 lapas
...information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration...contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for... | |
 | 1972 - 488 lapas
...this section and subparagraph (2) (11) of this paragraph) contains: (i) Adequate inf ormation for such use, including indications, effects, dosages, routes,...frequency and duration of administration, and any relevant warnings, hazards, contraindications, side effects, and precautions, and including information relevant... | |
 | 1981 - 730 lapas
...drug will also contain, in the same language and emphasis, informaTitle 21 — Food and Drugs tion for its use including indications, effects, dosages,...methods, and frequency and duration of administration, any relevant hazards, contraindications, side effects, and precautions contained in the labeling which... | |
 | 1997 - 200 lapas
...labeling; and (2) 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. (3) The information required, and in the format specified, by §{201.56 and 201.57. (e) All labeling... | |
 | 2003 - 210 lapas
...labeling; and (2) 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; Provided, however, That the information required by paragraphs (d) (1) and (2) of this section is not... | |
 | 2000 - 264 lapas
...amyl nitrite inhalant will be regarded as misbranded unless the labeling on or within the packajre from which the drug is to be dispensed bears adequate information for its safe and effective use by physicians, in accordance with §201.100(c) of this chapter, and its label... | |
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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,... 
