Details for New Drug Application (NDA): 019398
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NDA 019398 describes AMINOSYN-PF 7%, which is a drug marketed by Otsuka Icu Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the AMINOSYN-PF 7% profile page.
The generic ingredient in AMINOSYN-PF 7% 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 7% 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 019398
| Tradename: | AMINOSYN-PF 7% |
| Applicant: | Otsuka Icu Medcl |
| Ingredient: | amino acids |
| Patents: | 0 |
Suppliers and Packaging for NDA: 019398
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMINOSYN-PF 7% | amino acids | INJECTABLE;INJECTION | 019398 | NDA | ICU Medical Inc. | 0990-4178 | 0990-4178-03 | 12 BAG in 1 CASE (0990-4178-03) / 500 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 7% (7GM/100ML) | ||||
| Approval Date: | Sep 6, 1985 | TE: | RLD: | No | |||||
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