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 HYDROCODONE BITARTRATE از شرکت CENT PHARMS
Abbreviated New Drug Application (ANDA): 088898
Company: CENT PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND HYDROCODONE BITARTRATE | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 03/27/1985 | 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 |
|---|---|---|---|---|---|
| 11/29/1999 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/12/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/19/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/19/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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