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FDA updates labeling for BUPRENORPHINE HYDROCHLORIDE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 8
  • 0 comments

Labeling changes approved for HOSPIRA. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for SUBLIMAZE PRESERVATIVE FREE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 4
  • 0 comments

Labeling changes approved for RISING. Active ingredient: FENTANYL CITRATE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for NALBUPHINE HYDROCHLORIDE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 6
  • 0 comments

Labeling changes approved for HOSPIRA. Active ingredient: NALBUPHINE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for NUCYNTA

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 4
  • 0 comments

Labeling changes approved for COLLEGIUM PHARM INC. Active ingredient: TAPENTADOL HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for DILAUDID

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 4
  • 0 comments

Labeling changes approved for RHODES PHARMS. Active ingredient: HYDROMORPHONE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for DEMEROL

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 8
  • 0 comments

Labeling changes approved for QUAGEN. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA regulatory update for ELELYSO

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 2
  • 0 comments

Administrative update #SUPPL-34 for PFIZER. Status: Approval. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for MEPERGAN

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 5
  • 0 comments

Labeling changes approved for HIKMA. Active ingredient: MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for MEPERIDINE HYDROCHLORIDE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 0
  • 0 comments

Labeling changes approved for HIKMA. Active ingredient: MEPERIDINE HYDROCHLORIDE. Decision date: 12/22/2025

Comment Full text

FDA updates labeling for CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE

  • FDA Approval
  • Dec. 31, 2025, 13:45 UTC
  • 7
  • 0 comments

Labeling changes approved for INGENUS PHARMS NJ. Active ingredient: ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE. Decision date: 12/22/2025

Comment Full text
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