Details for New Drug Application (NDA): 017697
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The generic ingredient in KINEVAC is sincalide. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sincalide profile page.
Suppliers and Packaging for NDA: 017697
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697 | NDA | Bracco Diagnostics Inc. | 0270-0556 | 0270-0556-15 | 10 VIAL in 1 PACKAGE (0270-0556-15) / 5 mL in 1 VIAL |
KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697 | NDA | Fresenius Kabi USA, LLC | 63323-579 | 63323-579-05 | 10 VIAL in 1 PACKAGE (63323-579-05) / 5 mL in 1 VIAL (63323-579-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 0.005MG/VIAL | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 017697
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bracco | KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Bracco | KINEVAC | sincalide | POWDER;INTRAVENOUS | 017697-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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