Details for New Drug Application (NDA): 019492
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NDA 019492 describes AMINOSYN-PF 10%, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the AMINOSYN-PF 10% profile page.
The generic ingredient in AMINOSYN-PF 10% is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.
The generic ingredient in AMINOSYN-PF 10% is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 019492
| Tradename: | AMINOSYN-PF 10% |
| Applicant: | Icu Medical Inc |
| Ingredient: | amino acids |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019492
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOSYN-PF 10% | amino acids | INJECTABLE;INJECTION | 019492 | NDA | ICU Medical Inc. | 0990-4179 | 0990-4179-05 | 6 BAG in 1 CASE (0990-4179-05) / 1000 mL in 1 BAG |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10% (10GM/100ML) | ||||
| Approval Date: | Oct 17, 1986 | TE: | RLD: | No | |||||
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