The U.S. Food and Drug Administration has approved an Abbreviated New Drug Application (ANDA 204170) for Zolpidem Tartrate extended‑release tablets submitted by Sun Pharmaceutical Industries, Inc.
The product is marketed under the brand name Zolpidem Tartrate and is available as oral tablets in two strengths: 6.25 mg and 12.5 mg. Both dosage forms are prescription‑only and classified as human prescription drugs.
The approval follows the original submission (submission number 1) dated 2017‑01‑24 and a series of labeling supplement submissions (numbers 1, 6, 7, 9, and 15) that were approved on 2023‑03‑08.
The tablets are identified by National Drug Code (NDC) numbers 47335‑307‑88, 47335‑307‑13, 47335‑308‑88, and 47335‑308‑13.
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