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
BETAGAN از شرکت ALLERGAN
New Drug Application (NDA): 019219
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAGAN | LEVOBUNOLOL HYDROCHLORIDE | 0.5% | 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 |
|---|---|---|---|---|---|---|---|
| 12/19/1985 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019219Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2017 | SUPPL-29 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019219Orig1s029ltr.pdf |
||
| 12/16/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-20 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf |
||
| 05/14/2001 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 10/02/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/19/1998 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1998 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1998 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/06/1989 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/09/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 09/15/1987 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2017 | SUPPL-29 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019219s029lbl.pdf | |
| 08/08/2001 | SUPPL-20 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19219s20lbl.pdf |
BETAGAN
SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BETAGAN | LEVOBUNOLOL HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | Yes | AT | 019219 | ALLERGAN |
| LEVOBUNOLOL HYDROCHLORIDE | LEVOBUNOLOL HYDROCHLORIDE | 0.5% | SOLUTION/DROPS;OPHTHALMIC | Prescription | No | AT | 074326 | BAUSCH AND LOMB |
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