Mumbai, March 3 -- The company has acquired the abbreviated new drug application (ANDA) for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) single-dose vials from Aspen Pharma USA Inc.

Acetylcysteine is used for respiratory disease with excessive mucus. It acts as mucolytic (loosen mucus in airways) when used in oral preparations while when used as injection it treats paracetamol overdose toxicity.

The company's Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) single-dose vials can be expected to have the same therapeutic effect as the listed drug product upon which the agency relied as the basis of safety and effectiveness, Acetadote 2 Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials of Cumberland Pharmaceuticals Inc

According to ...