COLESTIPOL HYDROCHLORIDE | N020222 | PFIZER INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 2 - COLESTID PI FLAVORED COLESTID- colestipol hydrochloride granul... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C., on behalf of Pharmacia and Upjohn Company LLC, filed a suitability petition regarding Flavored COLESTID (colestipol hydrochloride granule, for suspension), seeking FDA assessment of the proposed formulation's suitability for approval under applicable regulatory pathway | Suitability | 2021-05-27 | Open | Hyman |
Attachment 3 - Colestipol hydrochloride PI Colestipol hydrochloride granules ... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C. filed a suitability petition regarding colestipol hydrochloride granules for oral suspension, requesting FDA determination of the suitability of the proposed product formulation and manufacturing process for approval under the applicable regulatory pathway. | Suitability | 2021-05-27 | Open | Hyman |
Attachment 1 - COLESTID Prescription Drug List re Suitability Petition from H... FDA-2021-P-0513 Hyman, Phelps & McNamara P.C. filed a petition regarding COLESTID's suitability for inclusion on a prescription drug list. The petition addresses regulatory considerations for COLESTID, a prescription medication, though the specific requested action and detailed rationale are not provided in this do | Suitability | 2021-05-27 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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