Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019715
Company: MYLAN SPCLT VIATRIS
Company: MYLAN SPCLT VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIPENTUM | OLSALAZINE SODIUM | 250MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1990 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019715s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019715Orig1s033ltr.pdf | |
| 11/16/2022 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019715s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019715Orig1s032ltr.pdf | |
| 11/01/2021 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019715s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019715Orig1s030ltr.pdf | |
| 06/25/2021 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019715s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019715Orig1s029ltr.pdf | |
| 10/07/2020 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019715s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019715Orig1s028ltr.pdf | |
| 08/05/2009 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019715s027ltr.pdf | |
| 07/10/2007 | SUPPL-25 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019715s025ltr.pdf |
| 11/12/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/09/2002 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715scs021ltr.pdf |
| 02/14/2001 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/08/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19715s18ltr.pdf |
| 06/30/1999 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 06/06/1996 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/31/1996 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/12/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/23/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1994 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/08/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 01/26/1995 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/15/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/05/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 10/24/2023 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019715s033lbl.pdf | |
| 11/16/2022 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019715s032lbl.pdf | |
| 11/01/2021 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019715s030lbl.pdf | |
| 06/25/2021 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019715s029lbl.pdf | |
| 10/07/2020 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019715s028lbl.pdf | |
| 08/05/2009 | SUPPL-27 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019715s027lbl.pdf |