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 100.
173. lappuse
... complies with the general regulations pertaining to imports under subpart E of part 1 . ( 2 ) A drug substance intended for use in the manufacture , processing , or re- packing of a new drug may be imported into the United States if it ...
... complies with the general regulations pertaining to imports under subpart E of part 1 . ( 2 ) A drug substance intended for use in the manufacture , processing , or re- packing of a new drug may be imported into the United States if it ...
334. lappuse
... complies with the regu- lations in this chapter and conforms to the applicable standards of identity , strength , quality , and purity pre- scribed by the regulations in this chap- ter ; the Commissioner shall certify that such batch is ...
... complies with the regu- lations in this chapter and conforms to the applicable standards of identity , strength , quality , and purity pre- scribed by the regulations in this chap- ter ; the Commissioner shall certify that such batch is ...
347. lappuse
... complies with section 502 ( 1 ) of the act or the cer- tification requirements of of section 512 ( n ) of the act or is so exempt . When the Commissioner finds that such application contains any untrue statement of a material fact or ...
... complies with section 502 ( 1 ) of the act or the cer- tification requirements of of section 512 ( n ) of the act or is so exempt . When the Commissioner finds that such application contains any untrue statement of a material fact or ...
518. lappuse
... complying with the re- quirements of §431.1 of this chapter , each such request shall contain : ( i ) Results of tests and assays on the batch for potency , moisture , pH , peni- cillin V content , and crystallinity . ( ii ) Samples ...
... complying with the re- quirements of §431.1 of this chapter , each such request shall contain : ( i ) Results of tests and assays on the batch for potency , moisture , pH , peni- cillin V content , and crystallinity . ( ii ) Samples ...
523. lappuse
... complying with the re- quirements of § 431.1 of this chapter , each such request shall contain : ( i ) Results of tests and assays on the batch for potency , sterility , pyrogens , moisture , and pH . ( ii ) Samples required : ( a ) If ...
... complying with the re- quirements of § 431.1 of this chapter , each such request shall contain : ( i ) Results of tests and assays on the batch for potency , sterility , pyrogens , moisture , and pH . ( ii ) Samples required : ( a ) If ...
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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