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
BLEPHAMIDE S.O.P. از شرکت ALLERGAN
Abbreviated New Drug Application (ANDA): 087748
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEPHAMIDE S.O.P. | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.2%;10% | OINTMENT;OPHTHALMIC | Prescription |
None |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/03/1986 | 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 |
|---|---|---|---|---|---|
| 08/15/2001 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/15/1999 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/23/1999 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1998 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/24/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/02/1993 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/29/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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