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
CYPROHEPTADINE HYDROCHLORIDE از شرکت ACTAVIS MID ATLANTIC
Abbreviated New Drug Application (ANDA): 086833
Company: ACTAVIS MID ATLANTIC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYPROHEPTADINE HYDROCHLORIDE | CYPROHEPTADINE HYDROCHLORIDE | 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SYRUP;ORAL | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 04/16/1980 | 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 |
|---|---|---|---|---|---|
| 10/02/2000 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/29/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/28/1990 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1990 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/26/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/11/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/03/1989 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1989 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/03/1989 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1989 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/05/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1982 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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