Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217462
Company: RICONPHARMA LLC
Company: RICONPHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/03/2024 | ORIG-1 | Approval | STANDARD |
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 | 217667 | EDENBRIDGE PHARMS |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 077510 | IMPAX LABS |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 220012 | PHARMOBEDIENT |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 217462 | RICONPHARMA LLC |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription | No | AB | 215223 | ZYDUS PHARMS |