Alembic Pharma bags USFDA approval for Pain relief injection Ketorolac Tromethamine
Ketorolac Tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain in adult patients.;
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Vadodara: Drugmaker Alembic Pharma today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials.
This is the second injectable product approval from the company's General Sterile Facility (F-3), which was inspected in August, 2022. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Toradol Injection, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL, of Roche Palo Alto, LLC.
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