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
CLEMASTINE FUMARATE از شرکت ANI PHARMS
Abbreviated New Drug Application (ANDA): 073282
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 1.34MG | TABLET;ORAL | Discontinued |
None |
No | No |
CLEMASTINE FUMARATE | CLEMASTINE FUMARATE | 1.34MG | 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 |
---|---|---|---|---|---|---|---|
01/31/1992 | 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 |
---|---|---|---|---|---|
08/30/2001 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
07/07/2000 | SUPPL-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/02/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/26/1996 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/13/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/25/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/27/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
10/03/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/26/1994 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/26/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/26/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/10/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/31/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/25/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/25/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/25/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/01/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/07/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/03/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/08/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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