Actavis Labs FL secures four labeling supplement approvals for bupropion HCl SR
FDA approved four separate labeling supplements for Actavis Labs FL's bupropion hydrochloride SR extended-release tablets on September 2, 2026.
Actavis Labs FL Inc. saw four labeling supplements for its generic bupropion hydrochloride SR extended-release tablets approved by FDA in the same batch this week, all tied to ANDA079095.
- Supplement 35, a labeling submission for bupropion hydrochloride SR extended-release tablets in 100mg, 150mg, and 200mg strengths, was approved.1
- Supplement 36, covering the same three-strength lineup of bupropion hydrochloride SR extended-release tablets, was approved.2
- Supplement 39, another labeling change for the identical 100mg, 150mg, and 200mg extended-release tablet strengths, was approved.3
- Supplement 44, again applying to the 100mg, 150mg, and 200mg extended-release tablet strengths, was approved.4
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