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FDA approves Boca Glycopyrrolate Tablet ANDA

The US Food and Drug Administration (FDA) has approved Boca Pharmacal's Glycopyrrolate Tablets' USP, 1 mg and 2 mg abbreviated new drug application (ANDA).

Glycopyrrolate tablets are used as adjunctive therapy to treat peptic ulcers.

Glycopyrrolate Tablets USP, 1 mg and 2 mg are generic equivalent to Robinul Tablets, 1 mg and Robinul Forte Tablets, 2 mg, distributed by Shionogi Pharma.

Boca Pharmacal CEO Robert Edwards said they are continuing to file new ANDAs, and will keep doing so in their ongoing effort to provide generic products to their customers and patients.