Details for New Drug Application (NDA): 204547
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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 204547
Tradename: | AMMONIA N 13 |
Applicant: | Precision Nuclear |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Pharmacology for NDA: 204547
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 204547
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 204547 | ANDA | Precision Nuclear LLC | 52768-100 | 52768-100-03 | 3 mL in 1 SYRINGE (52768-100-03) |
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 204547 | ANDA | Precision Nuclear LLC | 52768-100 | 52768-100-05 | 5 mL in 1 SYRINGE (52768-100-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 3.75mCi-260mCi/ML | ||||
Approval Date: | Aug 14, 2015 | TE: | AP | RLD: | No |
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