Ajanta Pharma’s Varenicline Tartrate Tablets Receive FDA Approval (ANDA213019)

The U.S. Food and Drug Administration (FDA) announced the approval of an Abbreviated New Drug Application (ANDA) numbered 213019 for varenicline tartrate tablets submitted by Ajanta Pharma Ltd. The products are oral tablets available in two strengths—equivalent to 0.5 mg and 1 mg of varenicline base. Both dosage forms are classified as prescription human drugs and are marketed by Ajanta Pharma USA Inc. The approval was issued on March 19, 2024, following a standard review. The tablets are identified by NDC codes 27241‑173‑56, 27241‑174‑56, 27241‑174‑11, 27241‑174‑77, and 27241‑187‑57.