Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020310
Company: KRAMER
Company: KRAMER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIZORAL ANTI-DANDRUFF | KETOCONAZOLE | 1% | SHAMPOO;TOPICAL | Over-the-counter | 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 |
|---|---|---|---|---|---|---|---|
| 10/10/1997 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20310_Nizoral.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/26/2025 | SUPPL-34 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020310Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020310Orig1s034ltr.pdf | |
| 07/05/2024 | SUPPL-33 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020310Orig1s033ltr.pdf | |
| 03/14/2024 | SUPPL-32 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020310Orig1s032ltr.pdf | |
| 09/29/2023 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020310Orig1s031ltr.pdf | |
| 01/19/2023 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020310Orig1s029ltr.pdf | |
| 05/13/2022 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020310Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020310Orig1s027ltr.pdf | |
| 02/02/2021 | SUPPL-26 | Labeling-Proprietary Name Change, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020310Orig1s026ltr.pdf |
| 04/20/2020 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020310orig1s024ltr.pdf | |
| 11/25/2019 | SUPPL-23 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020310Orig1s023ltr.pdf | |
| 11/30/2018 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020310s022lbl.pdf | |
| 01/03/2014 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/2010 | SUPPL-19 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020310s019ltr.pdf |
| 03/08/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/13/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/11/2000 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/22/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/13/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1998 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1998 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1998 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/06/1998 | 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 |
|---|---|---|---|---|---|
| 01/26/2025 | SUPPL-34 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020310Orig1s034lbl.pdf | |
| 07/05/2024 | SUPPL-33 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s033lbl.pdf | |
| 03/14/2024 | SUPPL-32 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020310Orig1s032lbl.pdf | |
| 09/29/2023 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s031lbl.pdf | |
| 01/19/2023 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020310Orig1s029lbl.pdf | |
| 05/13/2022 | SUPPL-27 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020310Orig1s027lbl.pdf | |
| 04/20/2020 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310orig1s024lbl.pdf | |
| 11/25/2019 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020310Orig1s023lbl.pdf | |
| 11/30/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020310s022lbl.pdf |
NIZORAL ANTI-DANDRUFF
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SHAMPOO;TOPICAL; 1%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| NIZORAL ANTI-DANDRUFF | KETOCONAZOLE | 1% | SHAMPOO;TOPICAL | Over-the-counter | Yes | 020310 | KRAMER |