COLESTIPOL HYDROCHLORIDE | A077277 | IMPAX LABORATORIES 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
Colestipol Hydrochloride (IMPAX Labs, NDA 077277) transitioned from prescription to discontinued status in the FDA database.
Old: RX
New: DISCN
Colestipol hydrochloride (Impax Labs, NDA 077277) therapeutic equivalence code changed from AB to a modified classification.
Old: AB
Impax Labs' colestipol hydrochloride (NDA 077277) therapeutic equivalence rating changed from AB.
Old: AB
Impax Labs' colestipol hydrochloride product (NDA 077277, supplement 002) transitioned from prescription (RX) to discontinued (DISCN) status in the FDA database.
Old: RX
New: DISCN