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
1.–5. rezultāts no 88.
14. lappuse
... cation , and containing no drug limited to prescription sale under the provi- sions of section 503 ( b ) ( 1 ) of the act . ( ii ) The phenyltoloxamine dihydro- gen citrate and all other components of the preparation meet their ...
... cation , and containing no drug limited to prescription sale under the provi- sions of section 503 ( b ) ( 1 ) of the act . ( ii ) The phenyltoloxamine dihydro- gen citrate and all other components of the preparation meet their ...
19. lappuse
... cation , and containing no drug limited to prescription sale under the provi- sions of section 503 ( b ) ( 1 ) of the act . ( ii ) The methoxyphenamine hydro- chloride and all other components of the preparation meet their professed ...
... cation , and containing no drug limited to prescription sale under the provi- sions of section 503 ( b ) ( 1 ) of the act . ( ii ) The methoxyphenamine hydro- chloride and all other components of the preparation meet their professed ...
25. lappuse
... cation shall contain : ( i ) A full list of the articles used as components of the digoxin product , specifications for components , detailed identification and analytical proce- dures used to assure that the compo- nents meet ...
... cation shall contain : ( i ) A full list of the articles used as components of the digoxin product , specifications for components , detailed identification and analytical proce- dures used to assure that the compo- nents meet ...
26. lappuse
... cation will be made on the basis of sample test results , inspectional find- ings regarding compliance with current good manufacturing practice , and com- pliance with all other requirements of this section and any other directives ...
... cation will be made on the basis of sample test results , inspectional find- ings regarding compliance with current good manufacturing practice , and com- pliance with all other requirements of this section and any other directives ...
34. lappuse
... cations for oral contraceptive drug products that are subject to the re- quirements of this section are required to submit supplements under §314.70 ( c ) of this chapter to provide for the label- ing required by this section . Such la ...
... cations for oral contraceptive drug products that are subject to the re- quirements of this section are required to submit supplements under §314.70 ( c ) of this chapter to provide for the label- ing required by this section . Such la ...
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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