Details for New Drug Application (NDA): 204352
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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 204352
Tradename: | AMMONIA N 13 |
Applicant: | Biomedcl Res Fdn |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Pharmacology for NDA: 204352
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 204352
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 204352 | ANDA | Biomedical Research Foundation of Northwest Louisiana | 24562-004 | 24562-004-30 | 30 mL in 1 VIAL, GLASS (24562-004-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 48.75mCi-487.5mCi/13ML (3.75-37.5mCi/ML) | ||||
Approval Date: | May 1, 2015 | TE: | AP | RLD: | No |
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