Department of Health and Human Services June 7, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other legal and regulatory requirements are met.
Determination That ATROVENT (Ipratropium Bromide) Metered Spray, 0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ATROVENT (ipratropium bromide) metered spray, 0.021 micrograms (mcg)/spray and 0.042 mcg/spray, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
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