Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017563
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Prescription | AB | Yes | No |
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Prescription | AB | Yes | Yes |
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Discontinued | None | Yes | No |
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/22/2014 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf |