Details for New Drug Application (NDA): 075880
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NDA 075880 describes PREMASOL 6% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the PREMASOL 6% IN PLASTIC CONTAINER profile page.
The generic ingredient in PREMASOL 6% IN PLASTIC CONTAINER 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 PREMASOL 6% IN PLASTIC CONTAINER 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 075880
| Tradename: | PREMASOL 6% IN PLASTIC CONTAINER |
| Applicant: | Baxter Hlthcare |
| Ingredient: | amino acids |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 075880
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREMASOL 10% IN PLASTIC CONTAINER | amino acids | INJECTABLE;INJECTION | 075880 | ANDA | Baxter Healthcare Corporation | 0338-1130 | 0338-1130-03 | 500 mL in 1 BAG (0338-1130-03) |
| PREMASOL 10% IN PLASTIC CONTAINER | amino acids | INJECTABLE;INJECTION | 075880 | ANDA | Baxter Healthcare Corporation | 0338-1130 | 0338-1130-04 | 1000 mL in 1 BAG (0338-1130-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 6% (6GM/100ML) | ||||
| Approval Date: | Jun 19, 2003 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10% (10GM/100ML) | ||||
| Approval Date: | Jun 19, 2003 | TE: | RLD: | No | |||||
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