NDC 43353-809

Sertraline 100 mg tablet, film coated

On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's a repackaged product: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Exelan Pharmaceuticals, Inc.'s NDC 76282-214.

Where the pills inside were made

Ascent Pharmaceuticals Inc

Central Islip, NY, United States · makes it, tests it and packages it

Problems found, fixed voluntarily Last FDA inspection Aug 9, 2024. 9 inspections on record.

InvaGen Pharmaceuticals, Inc

Hauppauge, NY, United States · makes it and tests it

No problems found Last FDA inspection Oct 25, 2023. 18 inspections on record.

InvaGen Pharmaceuticals, Inc

Central Islip, NY, United States · makes it, tests it and packages it

Problems found, fixed voluntarily Last FDA inspection Jul 17, 2026. 4 inspections on record.

Repackaging site

Product details

Generic drug
Sertraline: see every company that makes it
Form
tablet, film coated
Strength
100 mg
Approval
ANDA ANDA077397
On the market since
Aug 20, 2012
Package NDCs
43353-809-15 43353-809-30 43353-809-45 43353-809-53 43353-809-60 43353-809-73 43353-809-80
Official label
DailyMed (National Library of Medicine), updated Dec 19, 2019

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