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
BLEPH-10 از شرکت ALLERGAN
Abbreviated New Drug Application (ANDA): 080028
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLEPH-10 | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
Yes | Yes |
| BLEPH-30 | SULFACETAMIDE SODIUM | 30% | SOLUTION/DROPS;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 05/25/1971 | 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 |
|---|---|---|---|---|---|
| 11/15/2002 | SUPPL-49 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/03/2002 | SUPPL-48 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-47 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/07/2001 | SUPPL-45 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/13/2001 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/2000 | SUPPL-43 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/15/1998 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-41 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/14/1997 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1994 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 09/27/1994 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1993 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1993 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/02/1989 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1991 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1988 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 10/24/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1986 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/28/1982 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
BLEPH-10
SOLUTION/DROPS;OPHTHALMIC; 10%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BLEPH-10 | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 080028 | ALLERGAN |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040215 | AKORN |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 040066 | BAUSCH AND LOMB |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 089560 | SANDOZ INC |
BLEPH-30
There are no Therapeutic Equivalents.
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