Approval · Notice of Compliance 31257 · 2023
RECONCILE: Notice of Compliance 31257
Issued July 21, 2023
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
- 31257
- Date
- July 21, 2023
- Company
- Pegasus Laboratories IncPensacola, Florida, United States
- Product type
- Veterinary
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addiition of a drug substance manufacturing site
Products in this notice
Medicinal ingredients
- FLUOXETINE HYDROCHLORIDE 8 MG per TAB
- FLUOXETINE HYDROCHLORIDE 16 MG per TAB
- FLUOXETINE HYDROCHLORIDE 32 MG per TAB
- FLUOXETINE HYDROCHLORIDE 64 MG per TAB