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Details for New Drug Application (NDA): 019829
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NDA 019829 describes CERETEC, which is a drug marketed by Ge Healthcare and is included in one NDA. It is available from three suppliers. Additional details are available on the CERETEC profile page.
The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
The generic ingredient in CERETEC is technetium tc-99m exametazime kit. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the technetium tc-99m exametazime kit profile page.
Summary for 019829
| Tradename: | CERETEC |
| Applicant: | Ge Healthcare |
| Ingredient: | technetium tc-99m exametazime kit |
| Patents: | 0 |
Pharmacology for NDA: 019829
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 019829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829 | NDA | Medi-Physics Inc. dba GE Healthcare. | 17156-022 | 17156-022-05 | 5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL |
| CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829 | NDA | Medi-Physics Inc. | 17156-023 | 17156-023-05 | 1 KIT in 1 CARTON (17156-023-05) * 5 VIAL in 1 TRAY > 4.5 mL in 1 VIAL * 5 VIAL in 1 TRAY > 1 mL in 1 VIAL * 5 VIAL in 1 TRAY (17156-022-05) > 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Dec 30, 1988 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 019829
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Ge Healthcare | CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829-001 | Dec 30, 1988 | Start Trial | Start Trial |
| Ge Healthcare | CERETEC | technetium tc-99m exametazime kit | INJECTABLE;INJECTION | 019829-001 | Dec 30, 1988 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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