DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204356
The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.
Summary for 204356
Tradename: | AMMONIA N 13 |
Applicant: | Wi Medcl Cyclotron |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204356
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 204356
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 204356 | ANDA | Wisconsin Medical Cyclotron, LLC | 44338-002 | N | 44338-002-30 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 3.75-260mCi/ML | ||||
Approval Date: | Dec 18, 2014 | TE: | RLD: | No |
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