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
CODEINE SULFATE از شرکت HIKMA
New Drug Application (NDA): 022402
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | CODEINE SULFATE | 15MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CODEINE SULFATE | CODEINE SULFATE | 30MG | TABLET;ORAL | Prescription |
AB |
Yes | No |
| CODEINE SULFATE | CODEINE SULFATE | 60MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/2009 | ORIG-1 | Approval |
Type 7 – Drug Already Marketed without Approved NDA |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022402Orig1s014ltr.pdf |
||
| 10/07/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022402Orig1s012ltr.pdf |
||
| 09/18/2018 | SUPPL-11 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf |
||
| 09/18/2018 | SUPPL-10 | REMS – PROPOSAL – D-N-A |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022402Orig1s010s011ltr.pdf |
||
| 08/29/2017 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022402Orig1s009ltr.pdf |
||
| 12/16/2016 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022402Orig1s008ltr.pdf |
||
| 05/09/2013 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022402Orig1s006ltr.pdf |
||
| 06/17/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2012 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022402s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022402s014lbl.pdf | |
| 10/07/2019 | SUPPL-12 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf | |
| 10/07/2019 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022402s012lbl.pdf | |
| 09/18/2018 | SUPPL-11 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf | |
| 09/18/2018 | SUPPL-10 |
REMS – PROPOSAL – D-N-A |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022402s010s011lbl.pdf | |
| 08/29/2017 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022402s009lbl.pdf | |
| 12/16/2016 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf | |
| 12/16/2016 | SUPPL-8 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022402s008lbl.pdf | |
| 05/09/2013 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022402s006lbl.pdf | |
| 04/17/2012 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022402s003lbl.pdf | |
| 07/16/2009 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022402s000lbl.pdf |
CODEINE SULFATE
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | CODEINE SULFATE | 15MG | TABLET;ORAL | Prescription | Yes | AB | 022402 | HIKMA |
| CODEINE SULFATE | CODEINE SULFATE | 15MG | TABLET;ORAL | Prescription | No | AB | 203046 | LANNETT CO INC |
TABLET;ORAL; 30MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | CODEINE SULFATE | 30MG | TABLET;ORAL | Prescription | Yes | AB | 022402 | HIKMA |
| CODEINE SULFATE | CODEINE SULFATE | 30MG | TABLET;ORAL | Prescription | No | AB | 203046 | LANNETT CO INC |
TABLET;ORAL; 60MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | CODEINE SULFATE | 60MG | TABLET;ORAL | Prescription | Yes | AB | 022402 | HIKMA |
| CODEINE SULFATE | CODEINE SULFATE | 60MG | TABLET;ORAL | Prescription | No | AB | 203046 | LANNETT CO INC |
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