Details for New Drug Application (NDA): 203543
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NDA 203543 describes AMMONIA N 13, which is a drug marketed by 3d Imaging Drug, Biomedcl Res Fdn, Brigham Womens Hosp, Cardinal Hlth 414, Central Radiopharm, Decatur, Essential Isotopes, Feinstein, Gen Hosp, Ionetix, Johns Hopkins Univ, Kreitchman Pet Ctr, Mcprf, Methodist, Midwest Medcl, Mips Crf, Ncm Usa Bronx Llc, Nukemed, Petnet, Precision Nuclear, Shertech Labs Llc, Sofie, Ucla Biomedical, Ucsf Rodiopharm, Univ Alahama Birm, Univ Tx Md Anderson, Univ Tx Sw Medctr, Univ Wisconsin, Wa Univ Sch Med, and Wisconsin, and is included in thirty-one NDAs. It is available from twenty 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 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 suppliers are listed for this compound. Additional details are available on the ammonia n-13 profile page.
Summary for 203543
| Tradename: | AMMONIA N 13 |
| Applicant: | Sofie |
| Ingredient: | ammonia n-13 |
| Patents: | 0 |
Pharmacology for NDA: 203543
| Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 203543
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 203543 | ANDA | SOFIE Co. dba SOFIE | 49609-003 | 49609-003-01 | 30 mL in 1 VIAL, GLASS (49609-003-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 3.75mCi-260mCi/ML | ||||
| Approval Date: | Dec 14, 2012 | TE: | AP | RLD: | No | ||||
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