USFDA26 Jun 2025, 05:31 pm
JB Chemicals & Pharmaceuticals Ltd Receives US FDA Approval for Amitriptyline Hydrochloride Tablets
AI Summary
JB Chemicals & Pharmaceuticals Ltd has announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA), Amitriptyline Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. This product is indicated for relief of symptoms of depression.
Key Highlights
- JB Chemicals & Pharmaceuticals Ltd has received US FDA approval for Amitriptyline Hydrochloride Tablets USP
- The product is indicated for relief of symptoms of depression
- The approval covers six different dosage strengths: 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg