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): 019814
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETAGAN | LEVOBUNOLOL HYDROCHLORIDE | 0.25% | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 06/28/1989 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 03/19/2003 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/12/2002 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-12 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf |
||
| 05/14/2001 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf |
||
| 10/02/2000 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1998 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/18/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/18/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/04/1990 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/08/2001 | SUPPL-12 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814s12lbl.pdf |
| 05/14/2001 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19814S11lbl.pdf |
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