Details for New Drug Application (NDA): 078806
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NDA 078806 describes TECHNETIUM TC 99M SESTAMIBI, which is a drug marketed by Cardinal Health 414, Curium, Jubilant Draximage, and Sun Pharm Inds Inc, and is included in four NDAs. It is available from four suppliers. Additional details are available on the TECHNETIUM TC 99M SESTAMIBI profile page.
The generic ingredient in TECHNETIUM TC 99M SESTAMIBI is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.
The generic ingredient in TECHNETIUM TC 99M SESTAMIBI is technetium tc-99m sestamibi kit. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the technetium tc-99m sestamibi kit profile page.
Summary for 078806
| Tradename: | TECHNETIUM TC 99M SESTAMIBI |
| Applicant: | Jubilant Draximage |
| Ingredient: | technetium tc-99m sestamibi kit |
| Patents: | 0 |
Pharmacology for NDA: 078806
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 078806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC 99M SESTAMIBI | technetium tc-99m sestamibi kit | INJECTABLE;INJECTION | 078806 | ANDA | Jubilant Draximage (USA) Inc. | 45548-141 | 45548-141-05 | 5 VIAL in 1 KIT (45548-141-05) / 10 mL in 1 VIAL |
| TECHNETIUM TC 99M SESTAMIBI | technetium tc-99m sestamibi kit | INJECTABLE;INJECTION | 078806 | ANDA | Jubilant Draximage (USA) Inc. | 45548-141 | 45548-141-10 | 10 VIAL in 1 KIT (45548-141-10) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Apr 29, 2009 | TE: | AP | RLD: | No | ||||
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