Details for New Drug Application (NDA): 019018
✉ Email this page to a colleague
NDA 019018 describes TROPHAMINE 10%, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the TROPHAMINE 10% profile page.
The generic ingredient in TROPHAMINE 10% is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
The generic ingredient in TROPHAMINE 10% is amino acids. There are three hundred and fifty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 019018
| Tradename: | TROPHAMINE 10% |
| Applicant: | B Braun |
| Ingredient: | amino acids |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019018
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TROPHAMINE | amino acids | INJECTABLE;INJECTION | 019018 | NDA | B. Braun Medical Inc. | 0264-1933 | 0264-1933-10 | 12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER |
| TROPHAMINE 10% | amino acids | INJECTABLE;INJECTION | 019018 | NDA | B. Braun Medical Inc. | 0264-1933 | 0264-1933-10 | 12 CONTAINER in 1 CASE (0264-1933-10) / 500 mL in 1 CONTAINER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6% (6GM/100ML) | ||||
| Approval Date: | Jul 20, 1984 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10% (10GM/100ML) | ||||
| Approval Date: | Sep 7, 1988 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
