Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
CHLORAMPHENICOL | A060851 | ARMENPHARM
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Armenpharm, Ltd. - Citizen Petition FDA-2011-P-0081 Armenpharm, Ltd. filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA determine that Chloramphenicol Capsules USP, 250 mg (ANDA 060851) was withdrawn from sale for reasons other than safety or effectiveness and grant permission to relist the drug product in the Orange Book, | 505(q) | 2011-02-24 | Withdrawn | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.