The Food and Drug Administration (FDA or Agency) has determined that DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg, if all other legal and regulatory requirements are met.
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Determination That DORYX MPC (Doxycycline Hyclate), Delayed-Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 milligrams (mg), were not withdrawn from sale f...
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83 FR 10493
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“Determination That DORYX MPC (Doxycycline Hyclate), Delayed-Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (March 9, 2018), https://thefederalregister.org/documents/2018-04726/determination-that-doryx-mpc-doxycycline-hyclate-delayed-release-tablets-60-milligrams-were-not-withdrawn-from-sale-for-.