Details for New Drug Application (NDA): 019039
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NDA 019039 describes CIS-PYRO, 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-PYRO profile page.
The generic ingredient in CIS-PYRO is technetium tc-99m pyrophosphate 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 pyrophosphate kit profile page.
The generic ingredient in CIS-PYRO is technetium tc-99m pyrophosphate 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 pyrophosphate kit profile page.
Summary for 019039
| Tradename: | CIS-PYRO |
| Applicant: | Sun Pharm Inds Inc |
| Ingredient: | technetium tc-99m pyrophosphate kit |
| Patents: | 0 |
Pharmacology for NDA: 019039
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 019039
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CIS-PYRO | technetium tc-99m pyrophosphate kit | INJECTABLE;INJECTION | 019039 | NDA | Sun Pharmaceutical Industries, Inc. | 45567-0060 | 45567-0060-1 | 5 VIAL, MULTI-DOSE in 1 KIT (45567-0060-1) / 10 mL in 1 VIAL, MULTI-DOSE |
| CIS-PYRO | technetium tc-99m pyrophosphate kit | INJECTABLE;INJECTION | 019039 | NDA | Sun Pharmaceutical Industries, Inc. | 45567-0060 | 45567-0060-2 | 30 VIAL, MULTI-DOSE in 1 KIT (45567-0060-2) / 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: | Jun 30, 1987 | TE: | AP | RLD: | No | ||||
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