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
CHLOROQUINE PHOSPHATE از شرکت HIKMA PHARMS
Abbreviated New Drug Application (ANDA): 083082
Company: HIKMA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 500MG | TABLET;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 07/09/1975 | 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 |
|---|---|---|---|---|---|
| 05/29/2020 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/10/2009 | SUPPL-50 | Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf |
||
| 05/31/2007 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/21/2006 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 09/29/2005 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 07/11/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-39 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/30/2000 | SUPPL-38 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-37 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-36 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 09/17/1999 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1999 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 09/17/1999 | SUPPL-32 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 05/24/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1989 | SUPPL-21 | Bioequivalence |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/10/2009 | SUPPL-50 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/083082s050lbl.pdf |
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