DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204356
NDA 204356 describes AMMONIA N 13, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Health 414, Central Radiopharm, Essential Isotopes, Feinstein, Gen Hosp, Global Isotopes Llc, Houston Cyclotron, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Spectron Mrc Llc, Ucla Biomedical, Ucsf Rodiopharm, Univ Tx Md Anderson, Wa Univ Sch Med, and Wi Medcl Cyclotron, and is included in twenty-seven NDAs. It is available from twenty-three suppliers. Additional details are available on the AMMONIA N 13 profile page.
The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.
The generic ingredient in AMMONIA N 13 is ammonia n-13. There are two drug master file entries for this compound. Twenty-three 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 | 44338-002-30 | 30 mL in 1 VIAL, GLASS (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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