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
BILTRICIDE از شرکت BAYER HLTHCARE
New Drug Application (NDA): 018714
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BILTRICIDE | PRAZIQUANTEL | 600MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1982 | 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 |
|---|---|---|---|---|---|
| 01/08/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018714Orig1s018ltr.pdf |
||
| 11/20/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018714Orig1s013ltr.pdf |
||
| 08/16/2010 | SUPPL-12 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf |
||
| 07/14/2004 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf |
||
| 07/14/2004 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf |
||
| 11/07/1989 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/09/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/09/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/20/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/11/1983 | 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 |
|---|---|---|---|---|---|
| 01/08/2019 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf | |
| 01/08/2019 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf | |
| 02/25/2014 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf | |
| 08/16/2010 | SUPPL-12 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf | |
| 07/14/2004 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf | |
| 07/14/2004 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf |
BILTRICIDE
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BILTRICIDE | PRAZIQUANTEL | 600MG | TABLET;ORAL | Prescription | Yes | AB | 018714 | BAYER HLTHCARE |
| PRAZIQUANTEL | PRAZIQUANTEL | 600MG | TABLET;ORAL | Prescription | No | AB | 208820 | PAR PHARM INC |
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