Company

Senores Pharms

3 developments in the corpus

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AUG 6, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Pravastatin Sodium (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to an established statin; documents regulatory authorization but does not report clinical efficacy or comparative outcome data.

Regulatory UpdatePravastatin Sodium Senores Pharms

Reported

Approval date2026-08-06

Application numberANDA077491

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; describes a regulatory action, not a clinical trial or efficacy evidence.

Regulatory UpdateTramadol Hydrochloride Senores Pharms

Reported

Approval date2026-06-18

Dose50 mg

MAY 14, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Gabapentin (Manufacturing (CMC))

U.S. Food and Drug Administration

FDA supplemental approval for manufacturing changes to gabapentin formulations; does not report clinical efficacy or safety data.

Regulatory UpdateGabapentin Senores Pharms

Reported

Approval status date2026-05-14

Dosage strengths approved100 mg, 200 mg, 300 mg, 400 mg