The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA) numbered ANDA085911 for an oral tablet containing 5 mg oxycodone hydrochloride and 500 mg acetaminophen, marketed under the brand name Oxycodone 5/APAP 500.
The product, submitted by Bristol Myers Squibb, received an approval status (AP) on October 25, 1977. FDA records indicate the marketing status is listed as discontinued.
規制動向2026年9月19日•1分で読めます
FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet
FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.
PharmaCountryチームがまとめました · 出典： FDA.gov
評価
(0)
(0)
(0)
(0)
(0)
評価を残す