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
COLESTID از شرکت PFIZER
New Drug Application (NDA): 017563
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Prescription |
AB |
Yes | No |
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Prescription |
AB |
Yes | Yes |
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Prescription |
None |
Yes | No |
| FLAVORED COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Prescription |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/04/1977 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2018 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017563Orig1s024ltr.pdf |
|
| 05/22/2014 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017563Orig1s023,20222Orig1s005ltr.pdf |
||
| 09/22/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/09/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/18/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/01/1992 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/17/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/06/1993 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/06/1991 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/27/1990 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/03/1987 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/24/1986 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 02/19/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/17/1979 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/23/1979 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/16/1977 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/22/2014 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf |
COLESTID
GRANULE;ORAL; 5GM/SCOOPFUL
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Prescription | Yes | AB | 017563 | PFIZER |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 5GM/SCOOPFUL | GRANULE;ORAL | Prescription | No | AB | 077277 | IMPAX LABS |
GRANULE;ORAL; 5GM/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLESTID | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Prescription | Yes | AB | 017563 | PFIZER |
| COLESTIPOL HYDROCHLORIDE | COLESTIPOL HYDROCHLORIDE | 5GM/PACKET | GRANULE;ORAL | Prescription | No | AB | 077277 | IMPAX LABS |
FLAVORED COLESTID
There are no Therapeutic Equivalents.
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