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 از شرکت ALLERGAN
New Drug Application (NDA): 012813
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEPHAMIDE | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.2%;10% | SUSPENSION;OPHTHALMIC | Prescription |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/1961 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/18/2017 | SUPPL-62 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012813s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012813Orig1s062ltr.pdf |
||
| 03/19/2003 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/2001 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/21/2000 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/03/1999 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1998 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1998 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1997 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 12/02/1996 | SUPPL-42 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 06/22/1994 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1993 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1990 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1989 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1986 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/14/1986 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/1986 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1986 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1985 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1985 | SUPPL-30 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/25/1981 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/15/1982 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1980 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1978 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/18/2017 | SUPPL-62 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012813s062lbl.pdf |
نظرات کاربران