Approval · Notice of Compliance 3803 · 1997
NEUPOGEN: Notice of Compliance 3803
Issued January 16, 1997
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
- 3803
- Date
- January 16, 1997
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Changes in manufacturing facility, including multi-use activities
- Therapeutic class
- Haematopoietic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| NEUPOGEN | 01968017 | Marketed |
Medicinal ingredients
- FILGRASTIM (R-METHUG-CSF) 300 MCG per ML