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 LANNETT CO INC
Abbreviated New Drug Application (ANDA): 203046
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CODEINE SULFATE | CODEINE SULFATE | 15MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CODEINE SULFATE | CODEINE SULFATE | 30MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CODEINE SULFATE | CODEINE SULFATE | 60MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 06/13/2014 | 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 |
|---|---|---|---|---|---|
| 09/18/2018 | SUPPL-7 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
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 |
منبع : www.accessdata.fda.gov
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