FDA Approves ANDA063264 for Amikacin Sulfate Injection

The U.S. Food and Drug Administration has granted approval for ANDA063264, an Abbreviated New Drug Application covering an injectable form of Amikacin Sulfate. The product, submitted by Hospira, is administered by injection and is classified as an injectable dosage form (product number 001). It is not a reference drug and its marketing status is recorded as "Discontinued." The active ingredient is Amikacin Sulfate, equivalent to 250 mg base per milliliter. The approval record documents a series of supplemental submissions (SUPPL) that address labeling and manufacturing (CMC) requirements. Submissions span from 1994 to 2004 and include: original submission (1) on 1994‑11‑30; manufacturing supplements (2, 4, 5, 6, 7, 8, 10, 12) with dates ranging from 1996‑06‑18 to 2004‑03‑10; and labeling supplements (3, 6, 9, 11, 12) with dates from 2000‑01‑07 to 2004‑03‑10. All submissions have a status of "AP" (approved).