Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019845
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BETOPTIC S | BETAXOLOL HYDROCHLORIDE | EQ 0.25% BASE | SUSPENSION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 12/29/1989 | 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 |
|---|---|---|---|---|---|
| 06/09/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019845s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019845Orig1s030ltr.pdf | |
| 06/16/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-26 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019845s025lbl.pdf | |
| 02/01/2017 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019845s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019845Orig1s025ltr.pdf | |
| 05/08/2008 | SUPPL-21 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019845s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019845s021ltr.pdf | |
| 06/08/2007 | SUPPL-20 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019845s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019845s020ltr.pdf | |
| 05/09/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19845slr017_betopic_lblo.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19845slr017ltr.pdf | |
| 12/04/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/07/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/23/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1998 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/1991 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/20/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/09/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019845s030lbl.pdf | |
| 02/01/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019845s025lbl.pdf | |
| 03/24/2016 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019845s025lbl.pdf |
| 05/08/2008 | SUPPL-21 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019845s021lbl.pdf | |
| 06/08/2007 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019845s020lbl.pdf | |
| 05/09/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19845slr017_betopic_lblo.pdf |