Details for New Drug Application (NDA): 212819
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The generic ingredient in RECARBRIO is cilastatin sodium; imipenem; relebactam. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cilastatin sodium; imipenem; relebactam profile page.
Summary for 212819
Tradename: | RECARBRIO |
Applicant: | Msd Merck Co |
Ingredient: | cilastatin sodium; imipenem; relebactam |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212819
Generic Entry Date for 212819*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 212819
Mechanism of Action | Dipeptidase Inhibitors beta Lactamase Inhibitors |
Suppliers and Packaging for NDA: 212819
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RECARBRIO | cilastatin sodium; imipenem; relebactam | POWDER;INTRAVENOUS | 212819 | NDA | Merck Sharp & Dohme LLC | 0006-3856 | 0006-3856-02 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0006-3856-02) / 20 mL in 1 VIAL, SINGLE-DOSE (0006-3856-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL | ||||
Approval Date: | Jul 16, 2019 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Jul 16, 2029 | ||||||||
Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
Regulatory Exclusivity Expiration: | Jul 16, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 21, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI) |
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