FDA Approves Ranitidine Oral Syrup (ANDA077405)

The U.S. Food and Drug Administration (FDA) approved application ANDA077405 for a Ranitidine oral syrup. The product, marketed under the brand name Ranitidine, contains Ranitidine Hydrochloride at an equivalent strength of 15 mg per milliliter and is intended for oral administration. The syrup is produced by Pharmaceutical Associates, Inc., with the sponsor listed as PHARM ASSOC. It carries National Drug Code (NDC) identifiers 0121-0727-16 and 0121-4727-10. The product is classified as a human prescription drug and falls under the histamine‑2 receptor antagonist class. Regulatory submissions include an original filing (submission 1) approved on 21 Sep 2007, and several supplemental labeling approvals (submissions 1, 3, and 4) dated 28 May 2009, 31 Jan 2010, and 27 Oct 2010 respectively. The marketing status is noted as discontinued. These approvals reflect the FDA’s evaluation of the product’s safety, efficacy, and labeling compliance for the oral dosage form.