اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CHOLESTYRAMINE از شرکت ANI PHARMS
Abbreviated New Drug Application (ANDA): 074554
Company: ANI PHARMS
| 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 | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 10/02/1996 | 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 |
|---|---|---|---|---|---|
| 05/31/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-1 | Manufacturing (CMC) |
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 | 074554 | ANI PHARMS |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 077204 | PAR PHARM |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074557 | SANDOZ |
| 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 | 077203 | PAR PHARM |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 074558 | SANDOZ |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/PACKET | POWDER;ORAL | Prescription | No | AB | 209599 | TAGI |
| 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 | 074554 | ANI PHARMS |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 077204 | PAR PHARM |
| CHOLESTYRAMINE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074557 | SANDOZ |
| 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 | 077203 | PAR PHARM |
| CHOLESTYRAMINE LIGHT | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 074558 | SANDOZ |
| 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 |
| PREVALITE | CHOLESTYRAMINE | EQ 4GM RESIN/SCOOPFUL | POWDER;ORAL | Prescription | No | AB | 073263 | UPSHER SMITH LABS |
منبع : www.accessdata.fda.gov
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