FENTANYL | A076258 | MYLAN TECHNOLOGIES INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - "ANDA Suitability Petition for Fentanyl Citrate Injection USP"... FDA-2010-P-0413 Olsson Frank Weeda Terman Bode Matz PC filed a citizen petition requesting that the FDA determine fentanyl citrate injection USP is suitable for abbreviated new drug application approval, enabling generic manufacturers to pursue ANDA pathways for this injectable fentanyl product. | Suitability | 2010-08-10 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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