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): 020222
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESTID | COLESTIPOL HYDROCHLORIDE | 1GM | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/19/1994 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 05/25/2017 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020222Orig1s006ltr.pdf |
||
| 05/22/2014 | SUPPL-5 | 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 |
||
| 04/12/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/25/2017 | SUPPL-6 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf | |
| 05/25/2017 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf | |
| 05/22/2014 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf |
COLESTID
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 | 077510 | IMPAX LABS |
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