Actavis Elizabeth

JUL 14, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Metformin Hydrochloride (Labeling)

U.S. Food and Drug Administration

FDA supplemental approval for labeling of metformin hydrochloride extended-release tablet; a regulatory action that does not contain clinical trial data or efficacy evidence.

JUN 23, 2026 · REGULATORY APPROVAL

FDA approval: Gabapentin

U.S. Food and Drug Administration

This is an FDA approval record for a generic gabapentin formulation; it documents regulatory authorization but contains no clinical trial data or efficacy evidence.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Tramadol Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for tramadol hydrochloride extended-release tablets; this is a regulatory action, not a clinical efficacy study.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Morphine Sulfate (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for morphine sulfate extended-release capsules; indicates regulatory action to manage known risks but does not report clinical trial outcomes or efficacy data.