Details for New Drug Application (NDA): 018963
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The generic ingredient in CHOLETEC is technetium tc-99m mebrofenin kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m mebrofenin kit profile page.
Summary for 018963
Tradename: | CHOLETEC |
Applicant: | Bracco |
Ingredient: | technetium tc-99m mebrofenin kit |
Patents: | 0 |
Suppliers and Packaging for NDA: 018963
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CHOLETEC | technetium tc-99m mebrofenin kit | INJECTABLE;INJECTION | 018963 | NDA | Bracco Diagnostics Inc | 0270-0083 | 0270-0083-20 | 10 VIAL in 1 CARTON (0270-0083-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
Approval Date: | Jan 21, 1987 | TE: | AP | RLD: | Yes |
Expired US Patents for NDA 018963
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bracco | CHOLETEC | technetium tc-99m mebrofenin kit | INJECTABLE;INJECTION | 018963-001 | Jan 21, 1987 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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