Details for New Drug Application (NDA): 018107
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NDA 018107 describes TECHNETIUM TC-99M MEDRONATE KIT, which is a drug marketed by Cardinal Health 414 and is included in one NDA. It is available from one supplier. Additional details are available on the TECHNETIUM TC-99M MEDRONATE KIT profile page.
The generic ingredient in TECHNETIUM TC-99M MEDRONATE KIT is technetium tc-99m medronate 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 medronate kit profile page.
The generic ingredient in TECHNETIUM TC-99M MEDRONATE KIT is technetium tc-99m medronate 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 medronate kit profile page.
Summary for 018107
| Tradename: | TECHNETIUM TC-99M MEDRONATE KIT |
| Applicant: | Cardinal Health 414 |
| Ingredient: | technetium tc-99m medronate kit |
| Patents: | 0 |
Pharmacology for NDA: 018107
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 018107
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TECHNETIUM TC-99M MEDRONATE KIT | technetium tc-99m medronate kit | INJECTABLE;INJECTION | 018107 | NDA | Cardinal Health 414, LLC | 65857-505 | 65857-505-10 | 10 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (65857-505-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | N/A | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | No | ||||
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