Details for New Drug Application (NDA): 207025
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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 207025
Tradename: | AMMONIA N 13 |
Applicant: | Gen Hosp |
Ingredient: | ammonia n-13 |
Patents: | 0 |
Pharmacology for NDA: 207025
Mechanism of Action | Radiopharmaceutical Activity |
Suppliers and Packaging for NDA: 207025
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMMONIA N 13 | ammonia n-13 | INJECTABLE;INTRAVENOUS | 207025 | ANDA | Massachusetts General Hospital | 76318-643 | 76318-643-30 | 30 mL in 1 VIAL (76318-643-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 30mCi-300mCi/8ML (3.75-37.5mCi/ML) | ||||
Approval Date: | Feb 3, 2016 | TE: | AP | RLD: | No |
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