Approval · Notice of Compliance 14305 · 2013
REMODULIN: Notice of Compliance 14305
Issued April 19, 2013
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
- 14305
- Date
- April 19, 2013
- Company
- United Therapeutics CorporationDurham, North Carolina, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a new manufacturing and packaging site for drug product and a change to the manufacturing process
- Therapeutic class
- Vasodilator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REMODULIN | Not yet assigned | — |
Medicinal ingredients
- TREPROSTINIL SODIUM 1 MG per ML
- TREPROSTINIL SODIUM 2.5 MG per ML
- TREPROSTINIL SODIUM 5 MG per ML
- TREPROSTINIL SODIUM 10 MG per ML