TRIENTINE HYDROCHLORIDE | N019194 | BAUSCH HEALTH AMERICAS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Approval Response FDA-2015-P-4959 Cardinal Health Regulatory Sciences filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to submit an ANDA for Trientine Hydrochloride Capsules, 500 mg, a higher strength of the listed drug Syprine (trientine hydrochloride) Capsule | Suitability | 2020-12-01 | Granted | — |
Citizen Petition from Cardinal Health Regulatory Sciences FDA-2015-P-4959 Cardinal Health Regulatory Sciences filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for trientine hydrochloride capsules in 500-mg strength, which differs from the 250-m | Other | 2015-12-22 | Granted | Cardinal Health Regulatory Sciences |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.