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 IPCA LABS LTD
Abbreviated New Drug Application (ANDA): 090610
Company: IPCA LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 12/03/2009 | 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 |
|---|---|---|---|---|---|
| 03/26/2020 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090610Orig1s004,s005ltr.pdf |
||
| 03/26/2020 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/090610Orig1s004,s005ltr.pdf |
||
| 02/12/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/26/2020 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf | |
| 03/26/2020 | SUPPL-4 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf | |
| 03/26/2020 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/090610Orig1s004,s005lbl.pdf |
CHLOROQUINE PHOSPHATE
TABLET;ORAL; 250MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription | No | AA | 090610 | IPCA LABS LTD |
| CHLOROQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE | 250MG | TABLET;ORAL | Prescription | No | AA | 091621 | NATCO PHARMA LTD |
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