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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Meropenem
Date Designated: 04/27/2000
Orphan Designation: Management of acute pulmonary exacerbations, in cystic fibrosis patients, due to respiratory tract infection with susceptible organisms.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
AstraZeneca Pharmaceuticals
1800 Concord Pike
PO Box 15437
Wilmington, Delaware 19850
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.