Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073263
Company: UPSHER SMITH LABS
Company: UPSHER SMITH LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVALITE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | AB | No | No |
| PREVALITE | 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 |
|---|---|---|---|---|---|---|---|
| 02/22/1996 | 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 |
|---|---|---|---|---|---|
| 12/19/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/30/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
PREVALITE
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 | 077204 | ENDO OPERATIONS |
| 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 | 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 | PAR PHARM |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 209599 | TAGI |
| 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 | UPSHER SMITH LABS |
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 | 077204 | ENDO OPERATIONS |
| 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 | 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 | PAR PHARM |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 209599 | TAGI |
| 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 | UPSHER SMITH LABS |