Intas Pharmaceuticals Limited
Ahmedabad, India · makes it and tests it
No problems found Last FDA inspection Jul 12, 2024. 10 inspections on record.
NDC 67046-035
Amitriptyline Hydrochloride 100 mg tablet, film coated
On the label: Coupler Enterprises Inc..
It's a repackaged product: Coupler Enterprises Inc. rebottles it from Accord Healthcare Inc.'s NDC 16729-175.
Where the pills inside were made
Intas Pharmaceuticals Limited
Ahmedabad, India · makes it
Serious problems, FDA action Last FDA inspection Dec 2, 2022. 7 inspections on record, 1 with serious problems.
Repackaging site
- Coupler Enterprises, · repackages it
Product details
- Generic drug
- Amitriptyline: see every company that makes it
- Form
- tablet, film coated
- Strength
- 100 mg
- Approval
- ANDA ANDA202446
- On the market since
- Dec 5, 2014
- Package NDCs
67046-035-30- Official label
- DailyMed (National Library of Medicine), updated Sep 18, 2017
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