Details for New Drug Application (NDA): 022065
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The generic ingredient in IXEMPRA KIT is ixabepilone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ixabepilone profile page.
Summary for 022065
Tradename: | IXEMPRA KIT |
Applicant: | R-pharm Us Llc |
Ingredient: | ixabepilone |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022065
Generic Entry Date for 022065*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;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: 022065
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065 | NDA | R-Pharm US Operating, LLC | 70020-1910 | 70020-1910-1 | 1 KIT in 1 PACKAGE, COMBINATION (70020-1910-1) * 15 mg in 1 VIAL, SINGLE-USE * 8 mL in 1 VIAL, SINGLE-USE |
IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065 | NDA | R-Pharm US Operating, LLC | 70020-1911 | 70020-1911-1 | 1 KIT in 1 PACKAGE, COMBINATION (70020-1911-1) * 45 mg in 1 VIAL, SINGLE-USE * 23.5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 15MG/VIAL | ||||
Approval Date: | Oct 16, 2007 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 45MG/VIAL | ||||
Approval Date: | Oct 16, 2007 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 21, 2025 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022065
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-001 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
R-pharm Us Llc | IXEMPRA KIT | ixabepilone | INJECTABLE;INTRAVENOUS | 022065-002 | Oct 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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