DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205687
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 205687
Tradename: | AMMONIA N 13 |
Applicant: | Essential Isotopes |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205687
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 205687
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 205687 | ANDA | Essential Isotopes | 51760-003 | 51760-003-30 | 30 mL in 1 VIAL (51760-003-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 3.75-260mCi/ML | ||||
Approval Date: | Dec 17, 2015 | TE: | RLD: | No |
Complete Access Available with Subscription