The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for verapamil hydrochloride extended-release oral tablet, 180 mg, if all other legal and regulatory requirements are met.
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Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that CALAN SR (verapamil hydrochloride) extended-release oral tablet, 180 milligrams (mg), was not withdrawn from...
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81 FR 78606
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“Determination That CALAN SR (Verapamil Hydrochloride) Extended-Release Oral Tablet, 180 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (November 8, 2016), https://thefederalregister.org/documents/2016-26932/determination-that-calan-sr-verapamil-hydrochloride-extended-release-oral-tablet-180-milligrams-was-not-withdrawn-from-s.