Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074557
Company: EPIC PHARMA LLC
Company: EPIC PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | AB | No | Yes |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;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 |
|---|---|---|---|---|---|---|---|
| 08/15/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/26/2024 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1996 | SUPPL-1 | Labeling |
Label is not available on this site. |
CHOLESTYRAMINE
POWDER;ORAL; EQ 4GM RESIN/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 211119 | AJANTA PHARMA LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 211856 | ALKEM LABS LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074557 | EPIC PHARMA LLC |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 207294 | MACLEODS PHARMS LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 077204 | PH HEALTH |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 209597 | TAGI |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 211799 | ALKEM LABS LTD |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074558 | EPIC PHARMA LLC |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 077203 | PH HEALTH |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 209599 | PHARMOBEDIENT CNSLTG |
| LOCHOLEST | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074561 | CHARTWELL RX |
| LOCHOLEST LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074562 | CHARTWELL RX |
| PREVALITE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 073263 | AIPING PHARM INC |
POWDER;ORAL; EQ 4GM RESIN/SCOOPFUL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 211119 | AJANTA PHARMA LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 211856 | ALKEM LABS LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074557 | EPIC PHARMA LLC |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 207294 | MACLEODS PHARMS LTD |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 077204 | PH HEALTH |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 209597 | TAGI |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 202901 | ZYDUS PHARMS |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 211799 | ALKEM LABS LTD |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074558 | EPIC PHARMA LLC |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 077203 | PH HEALTH |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 209599 | PHARMOBEDIENT CNSLTG |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 202902 | ZYDUS PHARMS |
| LOCHOLEST | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074561 | CHARTWELL RX |
| LOCHOLEST LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074562 | CHARTWELL RX |
| PREVALITE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 073263 | AIPING PHARM INC |