THIAMINE HYDROCHLORIDE | A080509 | ABRAXIS PHARMACEUTICAL PRODUCTS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from JRRapoza Associates, Inc FDA-2017-P-7031 · 4 docket documents JRRapoza Associates, Inc. filed this citizen petition on behalf of a client requesting that the FDA Commissioner designate a new referenced standard drug for generic thiamine hydrochloride injection 100 mg/ml vials under NDA N080556 in the Orange Book, as the original reference drug product was comm | 505(q) | 2017-12-29 | Open | JRRapoza Associates, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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