Details for New Drug Application (NDA): 018124
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NDA 018124 describes CIS-MDP, which is a drug marketed by Sun Pharm Inds Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CIS-MDP profile page.
The generic ingredient in CIS-MDP 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 CIS-MDP 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 018124
| Tradename: | CIS-MDP |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | technetium tc-99m medronate kit |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018124
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 018124
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIS-MDP | technetium tc-99m medronate kit | INJECTABLE;INJECTION | 018124 | NDA | Sun Pharmaceutical Industries, Inc. | 45567-0040 | 45567-0040-1 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0040-1) / 10 mL in 1 VIAL, MULTI-DOSE |
| CIS-MDP | technetium tc-99m medronate kit | INJECTABLE;INJECTION | 018124 | NDA | Sun Pharmaceutical Industries, Inc. | 45567-0040 | 45567-0040-2 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0040-2) / 10 mL in 1 VIAL, MULTI-DOSE |
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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