Apl Healthcare Limited
Tirupati, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Dec 17, 2025. 5 inspections on record.
NDC 65862-012
Sertraline Hydrochloride 50 mg tablet, film coated
On the label: Aurobindo Pharma Limited.
Where it's made
Aurobindo Pharma Limited
Medchal, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection Jul 21, 2023. 13 inspections on record, 1 with serious problems.
Aurobindo Pharma Limited
Mahabubnagar, India · makes it and tests it
Problems found, fixed voluntarily Last FDA inspection May 10, 2022. 7 inspections on record, 1 with serious problems.
Product details
- Generic drug
- Sertraline: see every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 50 mg
- Approval
- ANDA ANDA077206
- On the market since
- Feb 6, 2007
- Package NDCs
65862-012-0165862-012-0565862-012-3065862-012-5065862-012-5165862-012-6065862-012-9065862-012-99- Official label
- DailyMed (National Library of Medicine), updated Feb 9, 2024
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