Code of Federal Regulations: Containing a Codification of Documents of General Applicability and Future Effect as of December 31, 1948, with Ancillaries and IndexDivision of the Federal Register, the National Archives, 1998 Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries. |
No grāmatas satura
11.–15. rezultāts no 100.
39. lappuse
... products are set forth in §310.501 . ( f ) Requirement to supplement approved application . Holders of approved appli- cations for estrogen drug products that are subject to the requirements of this section must submit supplements under ...
... products are set forth in §310.501 . ( f ) Requirement to supplement approved application . Holders of approved appli- cations for estrogen drug products that are subject to the requirements of this section must submit supplements under ...
40. lappuse
... Drug , and Cos- metic Act . However , a progestational drug product in the possession of a wholesaler or retailer before December 12 , 1978 , is not misbranded if adequate numbers of copies of the patient label- ing are furnished to the ...
... Drug , and Cos- metic Act . However , a progestational drug product in the possession of a wholesaler or retailer before December 12 , 1978 , is not misbranded if adequate numbers of copies of the patient label- ing are furnished to the ...
41. lappuse
... Drug products containing iron or iron salts . Drug products containing ... product contains 30 milligrams or more of iron per dos- age unit , it shall ... product , e.g. , tablet or capsule . Iron - containing drugs that are subject to ...
... Drug products containing iron or iron salts . Drug products containing ... product contains 30 milligrams or more of iron per dos- age unit , it shall ... product , e.g. , tablet or capsule . Iron - containing drugs that are subject to ...
42. lappuse
... drug product that is la- beled , represented , or promoted as an OTC daytime sedative ( or any similar or related indication ) is regarded as a new drug within the meaning of section 201 ( p ) of the Federal Food , Drug , and Cosmetic ...
... drug product that is la- beled , represented , or promoted as an OTC daytime sedative ( or any similar or related indication ) is regarded as a new drug within the meaning of section 201 ( p ) of the Federal Food , Drug , and Cosmetic ...
43. lappuse
... drug products for OTC use : “ acts as an aphrodisiac ; " " arouses or increases sexual desire and improves sexual ... product containing ingredients for use as an aphrodisiac cannot be generally recog- nized as safe and effective . ( b ) Any ...
... drug products for OTC use : “ acts as an aphrodisiac ; " " arouses or increases sexual desire and improves sexual ... product containing ingredients for use as an aphrodisiac cannot be generally recog- nized as safe and effective . ( b ) Any ...
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Bieži izmantoti vārdi un frāzes
abbre abbreviated application abbreviated new drug acid active ingredient adverse drug experience agency amended antibiotic application or abbreviated bacitracin bioavailability bioequivalence cation Center for Drug certification chapter clinical hold clinical investigation conducted control number copy Cosmetic Act digoxin dosage form dose Drug Administration drug application Drug Evaluation drug prod drug product Drug products containing drug substance Evaluation and Research Federal Food Food and Drug graph gredients hearing hydrochloride identified information requirements ap insulin intended inves investigational new drug labeling manufacturer marketing meet ment milligrams milliliters misbranded neomycin notice oral dosage orphan drug OTC drug product package paragraph percent person plication polymyxin proposed protocol recognized as safe reference listed drug request safe and effective safety section 502 Sodium sponsor statement submission Subpart sulfate tained tigational tion tive treatment treatment IND vestigational viated warning