Details for New Drug Application (NDA): 210303
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NDA 210303 describes ZEMDRI, which is a drug marketed by Cipla Usa and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the ZEMDRI profile page.
The generic ingredient in ZEMDRI is plazomicin sulfate. Three suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.
The generic ingredient in ZEMDRI is plazomicin sulfate. Three suppliers are listed for this compound. Additional details are available on the plazomicin sulfate profile page.
Summary for 210303
| Tradename: | ZEMDRI |
| Applicant: | Cipla Usa |
| Ingredient: | plazomicin sulfate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210303
Generic Entry Date for 210303*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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.
Suppliers and Packaging for NDA: 210303
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303 | NDA | Cipla USA Inc. | 69097-820 | 69097-820-96 | 10 VIAL in 1 CARTON (69097-820-96) / 10 mL in 1 VIAL (69097-820-37) |
| ZEMDRI | plazomicin sulfate | SOLUTION;INTRAVENOUS | 210303 | NDA | Achaogen, Inc. | 71045-010 | 71045-010-02 | 10 VIAL in 1 CARTON (71045-010-02) / 10 mL in 1 VIAL (71045-010-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | ||||
| Approval Date: | Jun 25, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 25, 2028 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Jun 25, 2023 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 8,383,596 | Patent Expiration: | Jun 2, 2031 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | METHOD OF USING PLAZOMICIN TO TREAT BACTERIAL INFECTIONS | ||||||||
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