U.S. FDA Requirements: Theophylline Sodium Glycinate
Pharmaceutical / Drug Definition :
Relaxes bronchial smooth muscles, suppressing airway response to stimuli. Also inhibits phosphodiesterase and release of slow-reacting substance of anaphylaxis and histamine
In the United States, Theophylline Sodium Glycinate is regulated by the U.S. Food and Drug Administration (FDA). FDA has specific requirements regarding the registration and listing of Theophylline Sodium Glycinate.
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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