Approval · Notice of Compliance 25647 · 2021
20% PROSOL: Notice of Compliance 25647
Issued April 13, 2021
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 25647
- Date
- April 13, 2021
- Company
- Baxter CorporationMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Alternate manufacturing site and update the product monograph to align with the 2016 format
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| 20% PROSOL | Not yet assigned | — |
Medicinal ingredients
- L-ALANINE 2.76 G per 100ML
- L-ASPARTIC ACID 0.6 G per 100ML
- GLUTAMIC ACID 1.02 G per 100ML
- GLYCINE 2.06 G per 100ML
- L-ARGININE 1.96 G per 100ML
- L-HISTIDINE HCL 1.18 G per 100ML
- L-ISOLEUCINE 1.08 G per 100ML
- L-LEUCINE 1.08 G per 100ML
- L-PHENYLALANINE 1 G per 100ML
- L-PROLINE 1.34 G per 100ML
- L-THREONINE 0.98 G per 100ML
- L-TRYPTOPHAN 0.32 G per 100ML
- L-VALINE 1.44 G per 100ML
- L-LYSINE ACETATE 1.35 G per 100ML
- METHIONINE 0.76 G per 100ML
- SERINE 1.02 G per 100ML
- L-TYROSINE 0.05 G per 100ML