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
ACTONEL WITH CALCIUM (COPACKAGED) از شرکت WARNER CHILCOTT
New Drug Application (NDA): 021823
Company: WARNER CHILCOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACTONEL WITH CALCIUM (COPACKAGED) | CALCIUM CARBONATE; RISEDRONATE SODIUM | EQ 500MG BASE;35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
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 |
|---|---|---|---|---|---|---|---|
| 08/12/2005 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2015 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s011ltr.pdf |
||
| 03/26/2015 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021823Orig1s010ltr.pdf |
||
| 04/19/2013 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021823Orig1s009ltr.pdf |
||
| 08/22/2011 | SUPPL-8 | REMS-Assessment |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s008ltr.pdf |
|
| 01/25/2011 | SUPPL-7 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf |
||
| 01/25/2011 | SUPPL-6 | REMS-Proposal |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021823s006,s007ltr.pdf |
||
| 08/22/2006 | SUPPL-4 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s004_LTR.pdf |
||
| 06/19/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021823s003LTR.pdf |
|
| 01/24/2006 | SUPPL-2 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020835s019_021823s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/08/2015 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s011lbl.pdf | |
| 03/26/2015 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021823s010lbl.pdf | |
| 04/19/2013 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021823s009lbl.pdf | |
| 01/25/2011 | SUPPL-7 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf | |
| 01/25/2011 | SUPPL-6 |
REMS-Proposal |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021823s006s007lbl.pdf | |
| 08/22/2006 | SUPPL-4 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021823s004_LBL.pdf | |
| 01/24/2006 | SUPPL-2 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020835s019, 021823s002lbl.pdf | |
| 08/12/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021823lbl.pdf |
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