Details for New Drug Application (NDA): 019785
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NDA 019785 describes MIRALUMA, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the MIRALUMA profile page.
The generic ingredient in MIRALUMA 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 MIRALUMA 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 019785
| Tradename: | MIRALUMA |
| Applicant: | Lantheus Medcl |
| Ingredient: | technetium tc-99m sestamibi kit |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019785
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARDIOLITE | technetium tc-99m sestamibi kit | INJECTABLE;INJECTION | 019785 | NDA | Lantheus Medical Imaging, Inc. | 11994-001 | 11994-001-20 | 20 VIAL in 1 BOX (11994-001-20) / 5 mL in 1 VIAL |
| CARDIOLITE | technetium tc-99m sestamibi kit | INJECTABLE;INJECTION | 019785 | NDA | Lantheus Medical Imaging, Inc. | 11994-001 | 11994-001-55 | 5 VIAL in 1 BOX (11994-001-55) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Dec 21, 1990 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | May 23, 1997 | TE: | RLD: | No | |||||
Expired US Patents for NDA 019785
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