Amneal Pharmaceuticals Receives FDA Approval for Nizatidine Oral Solution, the First Generic Oral Solution for Axid(R) in the Market

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HAUPPAUGE, N.Y.--(BUSINESS WIRE)--Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form and marks Amneal’s fourth liquid approval. It represents the company’s first exclusive generic – Amneal has 180-day exclusivity to market the product beginning from the date of first shipment.
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