DEXMEDETOMIDINE HYDROCHLORIDE | N206628 | HQ SPECIALTY PHARMA CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Orion Corporation, Orion Pharma FDA-2023-P-4551 · 7 docket documents Orion Corporation, Orion Pharma filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare dexmedetomidine hydrochloride injection 100 mcg base/mL in 4 mL and 10 mL single-dose vials suitable for an ANDA, with the refe | Suitability | 2023-10-17 | Granted | Orion Corporation, Orion Pharma |
Suitability Petition from Orion Corporation, Orion Pharma FDA-2023-P-1847 · 3 docket documents Orion Corporation, Orion Pharma submitted this suitability petition pursuant to section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Dexmedetomidine Hydrochloride Injection, 100 mcg base/mL in 4 mL and 10 mL single-dose vials suitable for consideration in an ANDA, based on the refere | Suitability | 2023-05-10 | Withdrawn | Orion Corporation, Orion Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.