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
BETOPTIC از شرکت SANDOZ INC
New Drug Application (NDA): 019270
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETOPTIC | BETAXOLOL HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 08/30/1985 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019270Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/05/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2016 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/2016 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/2014 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2006 | SUPPL-31 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019270s031ltr.pdf |
||
| 12/04/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1991 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/14/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/09/1990 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/19/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/31/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1986 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/12/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/12/1985 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 02/14/2006 | SUPPL-31 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/19270s031lbl.pdf |
BETOPTIC
SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 078694 | ACELLA |
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 075386 | AKORN |
| BETAXOLOL HYDROCHLORIDE | BETAXOLOL HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 075630 | MEDIMETRIKS PHARMS |
| BETOPTIC | BETAXOLOL HYDROCHLORIDE | EQ 0.5% BASE | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 019270 | SANDOZ INC |
نظرات کاربران