Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077510
Company: IMPAX LABS
Company: IMPAX LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/24/2006 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077510s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/09/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
COLESTIPOL HYDROCHLORIDE
TABLET;ORAL; 1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
COLESTID | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | Yes | AB | 020222 | PFIZER |
COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 216517 | ANI PHARMS |
COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 077510 | IMPAX LABS |
COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 215223 | ZYDUS PHARMS |