Announcing Dexcel Pharma USA, formerly known as Edenbridge Pharmaceuticals, LLC.

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Company Announcements

Loperamide Hydrochloride Capsules, USP Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Loperamide Hydrochloride Capsules USP, 2 mg, a generic version of Imodium®*...

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Methenamine Mandelate Tablets, USP Successful Filing

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has successfully filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for methenamine mandelate tablets USP, 500mg and 1,000mg. This filing joins another...

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Aminocaproic Acid Tablets, USP Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Aminocaproic Acid Tablets USP, 500 mg, a generic version of Amicar®* tablets,...

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Miglustat Capsules Launch

Parsippany, New Jersey. Edenbridge Pharmaceuticals announces the launch of its miglustat capsules 100mg. Generic version of Zavesca®* capsules being distributed by Orsini Specialty Pharmacy and offered with a co-pay program for eligible patients. Edenbridge...

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Bisoprolol Fumarate and Hydrochlorothiazide Tablets Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP (2.5mg/6.25mg,...

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Diltiazem Hydrochloride Tablets, USP Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Diltiazem Hydrochloride Tablets, USP (30 mg, 60 mg, 90 mg, and 120 mg), a...

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Albendazole Tablets, USP Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Albendazole Tablets USP 200mg, a generic version of Albenza®* tablets...

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Etodolac Tablets, USP Approval

Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC announces that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for Etodolac Tablets, USP, a generic version of Lodine®* tablets (Etodolac...

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