...evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying...

...accordance with a regulation or order under section 505(j) of the act and of § 310.300 of this chapter, or that the applicant has refused to permit access...Commissioner specifying the matter complained of. (4) That the applicant has failed to comply with the notice requirements of section 510(j)(2) of the...

...accordance with a regulation or order under section 505 (j) of the act and of S 310.300 of this chapter, or that the applicant has refused to permit access...Commissioner specifying the matter complained of. (4) That the applicant has failed to comply with the notice requirements of section 510(j) (2) of the...

...and preserve its identity, strength, quality, and purity; or (3) That on the basis of new Informatlon before the Food and Drug Administration, evaluated...Commissioner specifying the matter complained of. (4) That the applicant has failed to comply with the notice requirements of section 510(j)(2) of the...

...identity, strength, quality, and purity; or (3) That on the basis of new information before the Pood and Drug Administration, evaluated together with the...Commissioner specifying the matter complained of. (4) That the applicant has failed to comply with the notice requirements of section 510(j)(2) of the...

...after receipt of written notice from the agency. (3) That on the basis of new information before FDA, evaluated together with the evidence available when...facts, is false or misleading in any particular; and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice...

...after receipt of written notice from the agency. (3) That on the basis of new information before FDA, evaluated together with the evidence available when...facts, is false or misleading in any particular; and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice...

...information before FDA, evaluated together with the evidence available when the application or abbreviated application was approved, the labeling of the drug,...facts, is false or misleading in any particular, and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice...

...information before FDA, evaluated together with the evidence available when the application or abbreviated application was approved, the labeling of the drug,...facts, is false or misleading in any particular, and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice...

...information before FDA, evaluated together with the evidence available when the application or abbreviated application was approved, the labeling of the drug,...facts, is false or misleading in any particular, and the labeling was not corrected by the applicant within a reasonable time after receipt of written notice...