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XACDURO (COPACKAGED)
NDA · New Drug Application · Sponsor: ENTASIS THERAP · Approved 2023-05-23
Drug application
- FDA Application #
NDA216974- Application type
- New Drug Application
- Brand name
- XACDURO (COPACKAGED)
- Generic name
- SULBACTAM AND DURLOBACTAM
- Active ingredients
- DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
- Dosage form
- POWDER
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- ENTASIS THERAP
- Manufacturer
- La Jolla Pharmaceutical Company
- First approval
- 2023-05-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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