Novitium Pharma

RegulatoryJune 28, 2026

Novitium Pharma's Butalbital Combination Receives FDA Submission Approval

The FDA has approved a supplemental application for a combination product containing Butalbital, Aspirin, Caffeine, and Codeine Phosphate by Novitium Pharma.

Recent signals(10)

FDA Approves Pimozide Application ANDA219897 from Novitium Pharma

FDA Grants Approval for Pitolisant Hydrochloride by Novitium Pharma

FDA Grants Approval for Novitium's Tramadol Hydrochloride

Novitium Pharma's Aciclovir ANDA212252 Receives AP Status from FDA

FDA Grants Approval for Novitium Pharma's Rifampin ANDA219918

Novitium Pharma's Tramadol Hydrochloride ANDA219647 Receives AP Status

FDA Accepts Supplement for Naproxen by Novitium Pharma

Novitium Pharma's Butalbital Combination Receives FDA Submission Approval

FDA Accepts Supplemental Application for Tapentadol Hydrochloride by Novitium Pharma

FDA Grants Approval for Pimozide ANDA219897 by Novitium Pharma

Upcoming catalysts

Regulatory activity(4)

FDA Grants Approval for Novitium's Tramadol Hydrochloride

FDA Accepts Supplement for Naproxen by Novitium Pharma

Novitium Pharma's Butalbital Combination Receives FDA Submission Approval

FDA Accepts Supplemental Application for Tapentadol Hydrochloride by Novitium Pharma

Clinical activity

Competitive activity

Assets

Therapeutic areas

Indications

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