DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204515
The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.
Summary for 204515
Tradename: | AMMONIA N 13 |
Applicant: | Ncm Usa Bronx Llc |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204515
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 204515
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 204515 | ANDA | NCM USA Bronx LLC | 24445-643 | N | 24445-643-30 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 3.75-260mCi/mL | ||||
Approval Date: | Feb 4, 2015 | TE: | RLD: | No |
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