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
ACETAMINOPHEN AND CODEINE PHOSPHATE از شرکت KV PHARM
Abbreviated New Drug Application (ANDA): 085363
Company: KV PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 08/23/1977 | 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 |
|---|---|---|---|---|---|
| 06/26/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/22/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/12/1991 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/04/1988 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/24/1984 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1983 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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